510(k) K001995 ยท DQA Oximeter
SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER
| Applicant | Qrs Diagnostic, LLC, Plymouth MN, US |
| Decision | Substantially Equivalent, Sep 8, 2000 |
| Received | Jun 30, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001995
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.