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510(k) K915633

MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA by S & W Medico Teknik — Product Code FLL

K915633 is an FDA 510(k) premarket notification submitted by S & W Medico Teknik for the device "MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA". The FDA issued a decision of Substantially Equivalent on June 29, 1993. The device falls under product code FLL (Continuous Measurement Thermometer), a Class II device regulated under 21 CFR 880.2910. S & W Medico Teknik has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 1993
Date Received
October 29, 1991
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 S & W Medico Teknik

  • K964593 — DIASCOPE TRAVELLER PLUS (4053) (June 30, 1997)
  • K940933 — 9267 SPO2 ATHENA MODULE (November 29, 1995)
  • K942196 — 3050 DIASCOPE NT PATIENT MONITOR (June 28, 1995)
  • K913013 — TCPO2 9260 MODULE - SYSTEM ATHENA (May 3, 1994)
  • K934887 — 9750 ATHENA ETHERNET OPTION (January 14, 1994)
  • K930134 — 9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT (April 9, 1993)
  • K923418 — 9293/1 INTERFACE MODULE (February 23, 1993)
  • K911611 — SYSTEM ATHENA, MODIFICATION (February 5, 1993)
  • K922314 — VENTILATOR INTERFACE 9291/4 (December 17, 1992)
  • K912815 — NIBP 9225 COMBI (October 9, 1992)

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