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Ampmed AMPF2W

by Amplim, LLC

Ampmed AMPF2W is a Class II device made by Amplim, LLC, cleared under FDA 510(k) K181215 on 2 Jan 2019 and listed in FDA GUDID since 21 May 2021 (UDI-DI 00810477023651), 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) K181215

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 Number00810477023651 UDI-DI Date21 May 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK181215 Date2 Jan 2019IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K181215 decided 2 Jan 2019 Active
  • FDA GUDID UDI-DI 00810477023651 listed 21 May 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K181215
  2. Listed FDA GUDID 00810477023651

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  • Withdrawn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
AMPF2W
Primary DI / UDI-DI
00810477023651
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)