ComPAS2 2023.1.0
ComPAS2 2023.1.0 (CT1622) is a diagnostic spirometer (FDA Class II; FDA product code BZG, Spirometer, Diagnostic) made by Morgan Scientific, Inc., cleared under FDA 510(k) K213872 on 15 Jul 2022 and listed in FDA GUDID since 9 Aug 2023 (UDI-DI 00851845007187), 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 | GUDID listing | Number00851845007187 | Date9 Aug 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213872 | Date15 Jul 2022 | StatusActive |
Official records
- AccessGUDID record 00851845007187
- FDA 510(k) database K213872
Across registries
- FDA 510(k) K213872 decided 15 Jul 2022 Active
- FDA GUDID UDI-DI 00851845007187 listed 9 Aug 2023 Listed
Timeline
- Cleared FDA 510(k) K213872
- Listed FDA GUDID 00851845007187
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ComPAS2
- Generic name
- Diagnostic spirometer, professional
- Model / Ref / Catalog
- 2023.1.0, CT1622
- Primary DI / UDI-DI
- 00851845007187
- 510(k) Number
- FDA product code
- BZG
- GMDN term
- Diagnostic spirometer, professional
- Device class
- Class II
- Regulation number
- 868.1840
- GUDID distribution status
- In Commercial Distribution
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Other devices filed under Diagnostic spirometer, professional.