510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Interacoustics a/S

Middelfart Syddanmark, DK

INTERACOUSTICS A/S appears in FDA device records in Middelfart Syddanmark, DK. FDA records list 21 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
21
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 21 510(k) clearances for Interacoustics a/S between 2005 and 2020. The busiest year on record is 2020, with 3. The most recent is 2020, with 3.

Clearances by year, as a table
510(k) clearance decisions for Interacoustics a/S, by decision year
YearClearances
20052
20061
20071
20081
20092
20101
20111
20121
20132
20152
20172
20181
20191
20203
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K200534VisualEyesGWNSubstantially Equivalent
K200529OrionLXVSubstantially Equivalent
K192652TRVLXVSubstantially Equivalent
K191372LyraEWOSubstantially Equivalent
K173567SeraEWOSubstantially Equivalent
K163149VisualEyesGWNSubstantially Equivalent
K162037Eclipse with VEMPGWJSubstantially Equivalent
K152112VisualEyesGWNSubstantially Equivalent
K151616AT235ETYSubstantially Equivalent
K131681EYESEECAM VHITGWNSubstantially Equivalent
K130795TITANEWOSubstantially Equivalent
K121847TITANETYSubstantially Equivalent
K103760TITANGWJSubstantially Equivalent
K102364NYDIAG 200LXVSubstantially Equivalent
K090406EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULEEWOSubstantially Equivalent
K083861TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITEETYSubstantially Equivalent
K072254VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEMGWNSubstantially Equivalent
K070696INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)GWJSubstantially Equivalent
K060883PILOT TEST OR DETECTIVE AUDIOMETERSEWOSubstantially Equivalent
K052562ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.EWOSubstantially Equivalent
K043219AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMSEWOSubstantially Equivalent

Registered establishments

FDA registered establishments for Interacoustics a/S, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
97100513000254565INTERACOUSTICS A/SAudiometer Alle 1, Middelfart Syddanmark 5500 DK2026and 6 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Interacoustics a/S edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain