510(k) K913083

BI-TEMP TEMPERATURE MONITOR TM-201D by Respiratory Support Products, Inc. — Product Code FLL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 17, 1991
Date Received: May 23, 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 Respiratory Support Products, Inc.

K983862 — CLOUD 1 HUMIDIFICATION SYSTEM (May 24, 1999)
K921190 — ADAP-TEMP TEMPERATURE SENSOR ADAPTER (March 9, 1993)
K920469 — MYOCARDINAL TEMPERATURE SENSOR WITH TYPE 400 SERIE (September 11, 1992)
K921510 — GAS SAMPLING KIT MODIFICATION (June 11, 1992)
K913082 — BI-TEMP TEMPERATURE MONITOR,MODEL TM-300D (December 11, 1991)
K912280 — BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D (October 17, 1991)
K903816 — URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR (October 31, 1990)
K874694 — ADAP-TEMP, MODEL: AT-100 (March 1, 1988)
K873472 — MEMBRANE HUMIDIFIER (January 19, 1988)
K873205 — TYMPANIC TEMPERATURE SENSOR (January 14, 1988)

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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)
K240220 — Aulisa Temperature Module (TM0002) (September 27, 2024)