Ear Thermometer, Models ST613C and ST613F

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K011254 ↗

FDA Product Code

FLL

Device Class

Class II

Regulation

21 CFR Part 880.2910

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• 10-Second Digital Thermometer, Models ST87, ST89, ST80, ST88

  Class II

  FDA 510(k) K041056 Active Cleared 12 May 2004

• Thermometer Models ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F, ST8542C, and ST8542F

  Class II

  FDA 510(k) K013779 Active Cleared 29 Mar 2002

• 5 Sec Digital Clinical Thermometer, Models ST8630X, ST8640X, ST8730X, ST8740X, ST8930X, ST8940X, ST8030X, ST8040X

  Class II

  FDA 510(k) K050303 Active Cleared 25 Feb 2005

• Ear Thermometer Models ST61, ST62, ST63, ST64, and ST65

  Class II

  FDA 510(k) K042627 Active Cleared 18 Oct 2004

• Wireless Temperature Monitor / Models ST323C and ST323F.

  Class II

  FDA 510(k) K063542 Active Cleared 10 Apr 2007

• Digital Clinical Thermometer St-813A, St-814A, St-823 and St-823A

  Class II

  FDA 510(k) K962520 Active Cleared 12 Sep 1996

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