The following data is part of a premarket notification filed by Morgan Scientific, Inc. with the FDA for Compas2 (computerized Pulmonary Analysis System).
| Device ID | K190568 |
| 510k Number | K190568 |
| Device Name: | ComPAS2 (Computerized Pulmonary Analysis System) |
| Classification | Spirometer, Diagnostic |
| Applicant | Morgan Scientific, Inc. 151 Essex Street STE 8 Haverhill, MA 01832 |
| Contact | Deborah Cornish |
| Correspondent | Deborah Cornish Morgan Scientific, Inc. 151 Essex Street STE 8 Haverhill, MA 01832 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-06 |
| Decision Date | 2019-06-06 |