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Ampmed AMP1701AE2

by Amplim, LLC

Ampmed AMP1701AE2 is a Class II device made by Amplim, LLC, cleared under FDA 510(k) K171578 on 30 Nov 2017 and listed in FDA GUDID since 16 May 2019 (UDI-DI 00810477022197), 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) K171578

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 Number00810477022197 UDI-DI Date16 May 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK171578 Date30 Nov 2017IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K171578 decided 30 Nov 2017 Active
  • FDA GUDID UDI-DI 00810477022197 listed 16 May 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K171578
  2. Listed FDA GUDID 00810477022197

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  • Withdrawn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
AMP1701AE2
Primary DI / UDI-DI
00810477022197
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

  • Lot / batch number
Other properties (14, all answered No)