ComPAS 1.10
ComPAS 1.10 (2594) is a diagnostic spirometer (FDA Class II; FDA product code BZG, Spirometer, Diagnostic) made by Morgan Scientific, Inc., cleared under FDA 510(k) K190568 on 6 Jun 2019 (1 earlier submission) and listed in FDA GUDID since 1 Jun 2017 (UDI-DI 00851845007033), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK190568 | Date6 Jun 2019 | StatusActive |
| United States | GUDID listing | Number00851845007033 | Date1 Jun 2017 | StatusListed |
Official records
- AccessGUDID record 00851845007033
- FDA 510(k) database K190568
- FDA 510(k) database K021200
Across registries
- FDA 510(k) K190568 decided 6 Jun 2019 Active
- FDA GUDID UDI-DI 00851845007033 listed 1 Jun 2017 Listed
Timeline
- Cleared FDA 510(k) K021200
- Listed FDA GUDID 00851845007033
- Cleared FDA 510(k) K190568
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ComPAS
- Generic name
- Diagnostic spirometer, professional
- Model / Ref / Catalog
- 1.10, 2594
- Primary DI / UDI-DI
- 00851845007033
- FDA product code
- BZG
- GMDN term
- Diagnostic spirometer, professional
- Device class
- Class II
- Regulation number
- 868.1840
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Diagnostic spirometer, professional.