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Ampmed AMPW3A

by Amplim, LLC

Ampmed AMPW3A is a Class II device made by Amplim, LLC, cleared under FDA 510(k) K210565 on 5 May 2022 and listed in FDA GUDID since 6 May 2021 (UDI-DI 00810477023101), 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) K210565

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK210565 Date5 May 2022DecidedStatusActive
United StatesGUDID listing Number00810477023101 UDI-DI Date6 May 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K210565 decided 5 May 2022 Active
  • FDA GUDID UDI-DI 00810477023101 listed 6 May 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00810477023101
  2. Cleared FDA 510(k) K210565

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  • Withdrawn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
AMPW3A
Primary DI / UDI-DI
00810477023101
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

Related devices

Category: Infrared patient thermometer, skin

Cleared under the same submission (K210565)

and 2 more cleared under K210565

Similar devices in this category

Other devices filed under Infrared patient thermometer, skin.

Other devices from Amplim, LLC

See all devices from Amplim, LLC →

Properties

  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (12, all answered No)