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MGC Diagnostics 700023-905

by Medical Graphics Corporation 2 variants

MGC Diagnostics 700023-905 is a Class II device made by Medical Graphics Corporation, cleared under FDA 510(k) K070858 on 16 Apr 2007 and listed in FDA GUDID since 22 Feb 2019 (UDI-DI 00810016250005), active as of 8 Nov 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 8 Nov 2026

Documents

510(k) K070858

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810016250005 UDI-DI Date22 Feb 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK070858 Date16 Apr 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K070858 decided 16 Apr 2007 Active
  • FDA GUDID UDI-DI 00810016250005 listed 22 Feb 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K070858
  2. Listed FDA GUDID 00810016250005

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MGC Diagnostics
Generic name
Cardiopulmonary stress exercise monitoring system
Model / Ref / Catalog
700023-905
Primary DI / UDI-DI
00810016250005
510(k) Number
FDA product code
BZL
GMDN term
Cardiopulmonary stress exercise monitoring system
Device class
Class II
Regulation number
868.1730
GUDID distribution status
In Commercial Distribution

Similar devices

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

Other devices from Medical Graphics Corporation

See all devices from Medical Graphics Corporation →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)