510(k) K922106 ยท OLV Standard Polysomnograph With Electroencephalograph
ALICE
| Applicant | Healthdyne, Inc., Marietta GA, US |
| Decision | Substantially Equivalent, Jul 6, 1994 |
| Received | May 5, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922106
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2008 | Respironics, Inc. ECG Lead Set 60 in SOC to Snap model number 8049-1. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
GWO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.