ComPAS2 (Computerized Pulmonary Analysis System)
510(k) K190568
ComPAS2 (Computerized Pulmonary Analysis System) is a medical device (FDA Class II; FDA product code BZG, Spirometer, Diagnostic) made by Morgan Scientific, Inc., cleared under FDA 510(k) K190568 on 6 Jun 2019, 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 |
Official records
- FDA 510(k) database K190568
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- BZG
- Device class
- Class II
- Regulation
- 21 CFR Part 868.1840
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K190568
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| ComPAS 1.10 | 2594 / 1.10 | 00851845007033 | — | On the market |
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