510(k) K042843 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS
| Applicant | Ambu, Inc., Linthicum MD, US |
| Decision | Substantially Equivalent, Nov 12, 2004 |
| Received | Oct 14, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042843
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2014 | Exactech, Inc. NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13
intended to be implanted to replace a hip joint with our without bone cement. Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.