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Innocor INN00300

by Innovision ApS

Innocor INN00300 is a Class II device made by Innovision ApS, cleared under FDA 510(k) K071911 on 7 Sep 2007 (1 earlier submission) and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 05713867000018), 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

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05713867000018 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK071911 Date7 Sep 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K071911 decided 7 Sep 2007 Active· +1 more in the status table
  • FDA GUDID UDI-DI 05713867000018 listed 1 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K051907
  2. Cleared FDA 510(k) K071911
  3. Listed FDA GUDID 05713867000018

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Innocor
Generic name
Pulmonary function analysis system, paediatric
Model / reference
INN00300
Primary DI / UDI-DI
05713867000018
510(k) Number
FDA product code
DQK
GMDN term
Pulmonary function analysis system, paediatric
Device class
Class II
Regulation number
870.1425
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pulmonary function analysis system, adultCardiopulmonary stress exercise monitoring systemPulmonary function analysis system, paediatric

Cleared under the same submission (K051907)

and 8 more cleared under K051907

Cleared under the same submission (K071911)

and 8 more cleared under K071911

Similar devices

Other devices filed under FDA product code DQK (Computer, Diagnostic, Programmable).

Other devices from Innovision ApS

See all devices from Innovision ApS →

Properties

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