Ampmed AMPW3B

Ampmed AMPW3B 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 00810477023118), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00810477023118 UDI-DI	Date6 May 2021Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK180207	Date28 Nov 2018Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00810477023118
FDA 510(k) database 510(k) number K180207

Across registries

2 registries list this device

FDA 510(k) K180207 decided 28 Nov 2018 Active
FDA GUDID UDI-DI 00810477023118 listed 6 May 2021 Listed

Timeline

2 dated events

28 Nov 2018 Cleared FDA 510(k) K180207
6 May 2021 Listed FDA GUDID 00810477023118

Coverage

1 jurisdiction

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Withdrawn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: AMPW3B

Primary DI / UDI-DI: 00810477023118
510(k) Number: K180207
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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Other devices from Amplim, LLC

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Properties

Lot / batch number
Expiration date
Manufacturing date

Other properties (12, all answered No)