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510(k) K820670

HS17/HS18 SERIES MONITORS by Medtel Pty. , Ltd. — Product Code FLL

K820670 is an FDA 510(k) premarket notification submitted by Medtel Pty. , Ltd. for the device "HS17/HS18 SERIES MONITORS". The FDA issued a decision of Substantially Equivalent on April 9, 1982. The device falls under product code FLL (Continuous Measurement Thermometer), a Class II device regulated under 21 CFR 880.2910. Medtel Pty. , Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1982
Date Received
March 11, 1982
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 Medtel Pty. , Ltd.

  • K832356 — PORTABLE OPERAT. RM. MONITORS HS30/40 (October 28, 1983)
  • K820671 — CM10 CENTRAL MONITORING SYSTEM (April 1, 1982)
  • K820399 — HS20 PORT. OPERATING ROOM MONITOR (March 22, 1982)
  • K802184 — HS10 PORTABLE OPERATING ROOM MONITOR (September 26, 1980)
  • K800243 — D668 & D664 CENTRAL MONITORING SYSTEMS (April 10, 1980)
  • K791839 — H59 CRITICAL CARE MONITOR (October 1, 1979)
  • K791838 — HSH/H512 ADULT PHYSIOLOGICAL MONITORS (October 1, 1979)

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