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COSMED Quark C12x

by C O S M E D SRL

COSMED Quark C12x is a Class II device made by C O S M E D SRL, cleared under FDA 510(k) K000404 on 22 Nov 2000 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 18052400180263), 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) K000404

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 Number18052400180263 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK000404 Date22 Nov 2000IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K000404 decided 22 Nov 2000 Active
  • FDA GUDID UDI-DI 18052400180263 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K000404
  2. Listed FDA GUDID 18052400180263

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cosmed
Generic name
Cardiac stress exercise monitoring system
Model / reference
Quark C12x
Primary DI / UDI-DI
18052400180263
510(k) Number
FDA product code
MWI
GMDN term
Cardiac stress exercise monitoring system
Device class
Class II
Regulation number
870.2300
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cardiac stress exercise monitoring system

Cleared under the same submission (K000404)

Similar devices

Other devices filed under FDA product code MWI (Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)).

Other devices from C O S M E D SRL

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    Class II

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    Class II

  • COSMED Spiropalm 6MWT

    Class II

See all devices from C O S M E D SRL →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)