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Philips 215180

by Sbo Hearing A/S

Philips 215180 is a Class II device made by Sbo Hearing A/S, listed in FDA GUDID since 1 Dec 2020 (UDI-DI 05714464004560), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05714464004560 UDI-DI Date1 Dec 2020ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Philips
Generic name
Audiometric/hearing device software
Model / reference
215180
Primary DI / UDI-DI
05714464004560
FDA product code
KLW, OSM
GMDN term
Audiometric/hearing device software
Device class
Class II
Regulation number
874.3400, 874.3305
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Audiometric/hearing device software

Similar devices

Other devices filed under FDA product code KLW (Masker, tinnitus).

Other devices from Sbo Hearing A/S

  • Gpl

    Class IIa

  • Amplifon

    Class IIa

  • Hhm

    Class IIa

  • ViO

    Class IIa

See all devices from Sbo Hearing A/S →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)