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Ampmed AMP1707

by Amplim, LLC

Ampmed AMP1707 is a Class II device made by Amplim, LLC, cleared under FDA 510(k) K130231 on 15 Oct 2013 and listed in FDA GUDID since 11 Aug 2023 (UDI-DI 00810477023163), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K130231

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810477023163 UDI-DI Date11 Aug 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK130231 Date15 Oct 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K130231 decided 15 Oct 2013 Active
  • FDA GUDID UDI-DI 00810477023163 listed 11 Aug 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K130231
  2. Listed FDA GUDID 00810477023163

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ampmed
Generic name
Infrared patient thermometer, skin
Model / reference
AMP1707
Primary DI / UDI-DI
00810477023163
510(k) Number
FDA product code
FLL
GMDN term
Infrared patient thermometer, skin
Device class
Class II
Regulation number
880.2910
GUDID distribution status
In Commercial Distribution

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Properties

  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (12, all answered No)