The following data is part of a premarket notification filed by Morgan Scientific, Inc. with the FDA for Compas As (computerized Pulmonary Analysis System).
| Device ID | K013752 |
| 510k Number | K013752 |
| Device Name: | COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM) |
| Classification | Spirometer, Diagnostic |
| Applicant | MORGAN SCIENTIFIC, INC. 151 ESSEX ST. Haverhill, MA 01832 |
| Contact | Patrick Morgan |
| Correspondent | Patrick Morgan MORGAN SCIENTIFIC, INC. 151 ESSEX ST. Haverhill, MA 01832 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-13 |
| Decision Date | 2002-01-30 |