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510(k) K955846

MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETER by Y — Product Code FLL

K955846 is an FDA 510(k) premarket notification submitted by Y for the device "MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETER". The FDA issued a decision of Substantially Equivalent on October 1, 1996. The device falls under product code FLL (Continuous Measurement Thermometer), a Class II device regulated under 21 CFR 880.2910. Y has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1996
Date Received
December 26, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Continuous Measurement Thermometer
Device Class
Class II
Regulation Number
880.2910
Review Panel
HO
Submission Type

A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals. Under this regulation, this product code represents non-exempt devices. For more information, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf.

Other clearances by Y

  • K960280 — IVAC NEEDLE FREE VALVE ADMINISTRATION SETS (April 4, 1996)
  • K953225 — IVAC BALL VALCE ADMIN. SETS (September 27, 1995)
  • K934095 — IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETS (August 10, 1994)
  • K940897 — IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SET (June 22, 1994)
  • K931550 — EZ ADMINISTRATION SET (January 10, 1994)
  • K931549 — MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMP (October 12, 1993)
  • K922115 — IVAC NEEDLELESS INJECTION VALVE (October 12, 1993)
  • K932544 — IVAC SPACE SAVER VOLUMETRIC PUMP, MODEL 599 (October 12, 1993)
  • K930781 — INFUSION PUMP (August 19, 1993)
  • K925228 — IVAC 59 SERIES UNIVERSAL SET W/ ANTI-FREE FLOW VAL (July 30, 1993)

Other clearances for product code FLL

  • K253162 — Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (June 5, 2026)
  • K251160 — Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099L (January 8, 2026)
  • K250470 — Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E10 (June 23, 2025)
  • K243000 — Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature (June 20, 2025)
  • K250878 — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT (May 22, 2025)
  • K243082 — Infrared Thermometer (April 25, 2025)
  • K250401 — AION TempShield™ (March 14, 2025)
  • K243136 — Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR2 (February 14, 2025)
  • K240333 — Wearable Digital Thermometer (T31) (October 30, 2024)
  • K240223 — FMT Disposable and Autoclavable Temperature Probes (October 25, 2024)

FDA data resources