510(k) K110629 ยท BZD Ventilator, Non-Continuous (Respirator)
RESMART CPAP, RESMART AUTO-CPAP AND RESMART HUMIDIFIER
| Applicant | 3B Products, Inc., Potomac MD, US |
| Decision | Substantially Equivalent, Apr 27, 2012 |
| Received | Mar 4, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110629
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.