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Surface Temperature Scanner

by Omega Medical Corp.

510(k) K873010

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK873010 Date17 Nov 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FLL
Device Class
Class II
Regulation
21 CFR Part 880.2910
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

A surface temperature scanner is a medical device designed to measure the temperature of surfaces, particularly useful in clinical settings for monitoring temperature changes during procedures. It operates by detecting infrared radiation emitted from the surface.

The device is supplied by Omega Medical Corp. and has received FDA 510(k) clearance under K873010 with product code FLL. It is classified as a clinical electronic thermometer for general hospital use and was determined to be substantially equivalent to a predicate device on November 17, 1987.

Other devices from Omega Medical Corp.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Surface Temperature Scanner used for?

    The Surface Temperature Scanner is designed to measure the temperature of surfaces, particularly useful in clinical settings for monitoring temperature changes during procedures by detecting infrared radiation emitted from the surface.

  • How is the Surface Temperature Scanner supplied and by whom?

    The device is supplied by Omega Medical Corp., as stated in the manufacturer and applicant fields of the FDA 510(k) submission.

  • What regulatory clearance does the Surface Temperature Scanner have?

    The device has received FDA 510(k) clearance under K873010, with a decision date of November 17, 1987, and was determined to be substantially equivalent to a predicate device.

  • What is the product code and classification of the Surface Temperature Scanner?

    The device has product code FLL and is classified as a clinical electronic thermometer for general hospital use, under advisory committee HO (General Hospital).