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Fitmate Series

by COSMED Srl

510(k) K071533

Fitmate Series is a Class II device made by COSMED Srl, cleared under FDA 510(k) K071533 on 28 Sep 2007, 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 NumberK071533 Date28 Sep 2007ClearedStatusActive

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  • Withdrawn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
BZL
Device class
Class II
Regulation
21 CFR Part 868.1730
Advisory committee
Anesthesiology
FDA decision
SESE Substantially Equivalent

Devices cleared under K071533

4 devices · 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 K071533
UDI-DISize and differences
COSMED Fitmate
C O S M E D SRL
Fitmate18052400180201 —On the market
COSMED Fitmate GS
C O S M E D SRL
Fitmate GS18052400180362 —On the market
COSMED Fitmate Med
C O S M E D SRL
Fitmate Med18052400180249 —On the market
COSMED Fitmate Pro
C O S M E D SRL
Fitmate Pro18052400180225 —On the market

Similar devices

Other devices filed under FDA product code BZL (Computer, Oxygen-Uptake).

Other devices from COSMED Srl

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