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Battery P15051-27

by Fujifilm Sonosite, Inc.

Battery P15051-27 is a Class II device made by Fujifilm Sonosite, Inc., cleared under FDA 510(k) K133454 on 16 Dec 2013, registered in EUDAMED and listed in FDA GUDID since 3 Feb 2025 (UDI-DI 00841517110840), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K133454

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00841517110840 UDI-DI Date3 Feb 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK133454 Date16 Dec 2013IssuedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K133454 decided 16 Dec 2013 Active
  • EUDAMED Active· +1 more in the status table
  • FDA GUDID UDI-DI 00841517110840 listed 3 Feb 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K133454
  2. Listed FDA GUDID 00841517110840

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Battery
Generic name
Portable/mobile rechargeable battery pack
Model / Ref / Catalog
P15051-27, P15051
Description
Diagnostic Ultrasound System Accessory. Battery mounted internally within an ultrasound system.
Primary DI / UDI-DI
00841517110840
510(k) Number
FDA product code
ITX, IYN, IYO
GMDN term
Portable/mobile rechargeable battery pack
Device class
Class II
Regulation number
892.1570, 892.1550, 892.1560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Portable/mobile rechargeable battery pack

Cleared under the same submission (K133454)

and 8 more cleared under K133454

Similar devices in this category

Other devices filed under Portable/mobile rechargeable battery pack.

Other devices from Fujifilm Sonosite, Inc.

See all devices from Fujifilm Sonosite, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)