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Interacoustics Sera

by Interacoustics A/S

Interacoustics Sera is a Class II device made by Interacoustics A/S, cleared under FDA 510(k) K173567 on 14 Feb 2018 and listed in FDA GUDID since 28 Jul 2026 (UDI-DI 05711117244540), 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) K173567

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 Number05711117244540 UDI-DI Date28 Jul 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK173567 Date14 Feb 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K173567 decided 14 Feb 2018 Active
  • FDA GUDID UDI-DI 05711117244540 listed 28 Jul 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K173567
  2. Listed FDA GUDID 05711117244540

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Interacoustics
Generic name
Otoacoustic emission system, battery-powered
Model / reference
Sera
Primary DI / UDI-DI
05711117244540
510(k) Number
FDA product code
GWJ, EWO
GMDN term
Otoacoustic emission system, battery-powered
Device class
Class II
Regulation number
882.1900, 874.1050
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K173567)

Other devices from Interacoustics A/S

See all devices from Interacoustics A/S →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)