510(k) K822939

HEART RATE & TEMP. MEASUREMENT SYSTEM by Camino Laboratories, Inc. — Product Code FLL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 24, 1982
Date Received: October 4, 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 Camino Laboratories, Inc.

K932769 — CAMINO VENTRICULAR DRAINAGE SYSTEM (March 30, 1995)
K930221 — CAMINO VENTRICULAR TRANSDUCER ACCESSORY (April 15, 1993)
K930222 — CAMINO VENTRICULAR ACCESS DEVICE (April 15, 1993)
K920088 — CAMINO VENTRICULAR NEEDLE (May 1, 1992)
K914735 — VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM (January 17, 1992)
K912833 — CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAY (September 23, 1991)
K893232 — MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM (July 14, 1989)
K881183 — VENTRICULAR BOLT PRESSURE MONITORING KIT #110-4H (May 4, 1988)
K863969 — CAMINO COMPARTMENTAL PRESS MONITOR CATH/110-4D (May 27, 1987)
K861961 — CAMINO CSF DRAINAGE SYSTEM MODEL 040 (August 12, 1986)

Other clearances for product code FLL

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