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Resonance R15C

by M.R.S. SRL

Resonance R15C (4300104300) is a Class II device made by M.R.S. SRL, cleared under FDA 510(k) K031978 on 21 Jul 2003 and listed in FDA GUDID since 1 Sep 2025 (UDI-DI 08051597160051), active as of 23 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 23 Oct 2026

Documents

510(k) K031978

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08051597160051 UDI-DI Date1 Sep 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK031978 Date21 Jul 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K031978 decided 21 Jul 2003 Active
  • FDA GUDID UDI-DI 08051597160051 listed 1 Sep 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K031978
  2. Listed FDA GUDID 08051597160051

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Resonance
Generic name
Tone audiometer
Model / Ref / Catalog
R15C, 4300104300
Primary DI / UDI-DI
08051597160051
510(k) Number
FDA product code
ETY
GMDN term
Tone audiometer
Device class
Class II
Regulation number
874.1090
GUDID distribution status
In Commercial Distribution

Related devices

Category: Otoacoustic emission system, battery-poweredImpedance audiometerTone audiometerSpeech audiometer

Cleared under the same submission (K031978)

Similar devices

Other devices filed under FDA product code ETY (Tester, Auditory Impedance).

Other devices from M.R.S. SRL

Properties

  • Serial number
Other properties (14, all answered No)