MGC Diagnostics 800840-011
by Medical Graphics Corporation 2 variants
MGC Diagnostics 800840-011 is a Class II device made by Medical Graphics Corporation, cleared under FDA 510(k) K061731 on 6 Sep 2006 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI B368800840011), active as of 8 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB368800840011 | Date9 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK061731 | Date6 Sep 2006 | StatusActive |
Official records
- FDA 510(k) database K061731
Across registries
- FDA 510(k) K061731 decided 6 Sep 2006 Active
- FDA GUDID UDI-DI B368800840011 listed 9 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K061731
- Listed FDA GUDID B368800840011
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MGC Diagnostics
- Generic name
- Cardiopulmonary stress exercise monitoring system
- Model / Ref / Catalog
- 800840-011
- Primary DI / UDI-DI
- B368800840011
- 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
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