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Ampmed AMPW1W

by Amplim, LLC

Ampmed AMPW1W is a Class II device made by Amplim, LLC, cleared under FDA 510(k) K180207 on 28 Nov 2018 and listed in FDA GUDID since 6 May 2021 (UDI-DI 00810477023620), 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) K180207

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 Number00810477023620 UDI-DI Date6 May 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK180207 Date28 Nov 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K180207 decided 28 Nov 2018 Active
  • FDA GUDID UDI-DI 00810477023620 listed 6 May 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K180207
  2. Listed FDA GUDID 00810477023620

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  • Withdrawn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
AMPW1W
Primary DI / UDI-DI
00810477023620
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

Similar devices

Other devices filed under FDA product code FLL (Thermometer, Electronic, Clinical).

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)