Skip to content

Cortex Metamax

by Cortex Biophysik GmbH

510(k) K001631

Cortex Metamax is a Class II device made by Cortex Biophysik GmbH, cleared under FDA 510(k) K001631 on 22 Feb 2001, active as of 11 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 11 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 11 Oct 2026.

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK001631 Date22 Feb 2001ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
BZC
Device class
Class II
Regulation
21 CFR Part 868.1880
Advisory committee
Anesthesiology
FDA decision
SESE Substantially Equivalent

Devices cleared under K001631

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K001631
UDI-DISize and differences
CORTEX CPET system MetaMax3B
Cortex Biophysik GmbH
MetaMax3B74250179232794 —On the market

Similar devices

Other devices filed under FDA product code BZC (Calculator, Pulmonary Function Data).

Other devices from Cortex Biophysik GmbH