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MGC Diagnostics 536756-KNC

by Medical Graphics Corporation

MGC Diagnostics 536756-KNC is a pulmonary function testing kit (FDA Class II; FDA product code BZG, Spirometer, Diagnostic) made by Medical Graphics Corporation, cleared under FDA 510(k) K042758 on 29 Aug 2005 and listed in FDA GUDID since 1 Jun 2019 (UDI-DI 00810016251699), 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) K042758

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 Number00810016251699 UDI-DI Date1 Jun 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK042758 Date29 Aug 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K042758 decided 29 Aug 2005 Active
  • FDA GUDID UDI-DI 00810016251699 listed 1 Jun 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K042758
  2. Listed FDA GUDID 00810016251699

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  • Withdrawn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
Pulmonary function testing kit
Model / reference
536756-KNC
Primary DI / UDI-DI
00810016251699
510(k) Number
FDA product code
BZG
GMDN term
Pulmonary function testing kit
Device class
Class II
Regulation number
868.1840
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code BZG (Spirometer, Diagnostic).

Other devices from Medical Graphics Corporation

See all devices from Medical Graphics Corporation →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Serial number
  • Manufacturing date
Other properties (10, all answered No)