Skip to content

Ampmed AMP1701AE3

by Amplim, LLC

Ampmed AMP1701AE3 is a Class II device made by Amplim, LLC, cleared under FDA 510(k) K191251 on 15 Oct 2019 and listed in FDA GUDID since 17 Mar 2020 (UDI-DI 00810477022838), 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) K191251

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 Number00810477022838 UDI-DI Date17 Mar 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK191251 Date15 Oct 2019IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K191251 decided 15 Oct 2019 Active
  • FDA GUDID UDI-DI 00810477022838 listed 17 Mar 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K191251
  2. Listed FDA GUDID 00810477022838

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  • Withdrawn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
AMP1701AE3
Primary DI / UDI-DI
00810477022838
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 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)