K140707 is an FDA 510(k) clearance for the LIFEBORNE INFANT RESUSCITATOR. This device is classified as a Ventilator, Emergency, Powered (resuscitator) (Class II - Special Controls, product code BTL).
Submitted by International Biomedical (Austin, US). The FDA issued a Cleared decision on May 28, 2014, 69 days after receiving the submission on March 20, 2014.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5925.
| 510(k) Number | K140707 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2014 |
| Decision Date | May 28, 2014 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTL - Ventilator, Emergency, Powered (resuscitator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5925 |