K042843 is an FDA 510(k) clearance for the AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS. This device is classified as a Ventilator, Emergency, Manual (resuscitator) (Class II - Special Controls, product code BTM).
Submitted by Ambu, Inc. (Linthicum, US). The FDA issued a Cleared decision on November 12, 2004, 29 days after receiving the submission on October 14, 2004.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5915.
| 510(k) Number | K042843 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 2004 |
| Decision Date | November 12, 2004 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BTM — Ventilator, Emergency, Manual (resuscitator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5915 |