510(k) K190568 ยท BZG Spirometer, Diagnostic
ComPAS2 (Computerized Pulmonary Analysis System)
| Applicant | Morgan Scientific, Inc., Haverhill MA, US |
| Decision | Substantially Equivalent, Jun 6, 2019 |
| Received | Mar 6, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190568
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.