510(k) K060006

BRAUN THERMOSCAN IRT 2000 INFRARED EAR THERMOMETER by Braun GmbH — Product Code FLL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 31, 2006
Date Received: January 3, 2006
Clearance Type: Special
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 Braun GmbH

K061351 — ORAL-B SONIC COMPLETE (June 5, 2006)
K061199 — ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES (May 31, 2006)
K031928 — BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT); BRAUN THERMOSCA (October 24, 2003)
K012035 — BRAUN PRECISION SENSOR PRO, MODEL BP 2590 (July 27, 2001)
K003732 — BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES (May 16, 2001)
K992468 — BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER (October 20, 1999)
K983295 — BRAUN THERMOSCAN IRT3020/3500 ONE SECONS EAR THERMOMETER, MODEL IRT3020/3520 (March 15, 1999)
K844339 — BRAUN DENTAL CENTER OC-3 (February 8, 1985)

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)