510(k) K915633

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

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)

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K250878 — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT (May 22, 2025)
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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)
K240220 — Aulisa Temperature Module (TM0002) (September 27, 2024)