K182956 is an FDA 510(k) clearance for the Puffin Lite Infant Resuscitation System. 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 January 18, 2019, 86 days after receiving the submission on October 24, 2018.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5925.
| 510(k) Number | K182956 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 24, 2018 |
| Decision Date | January 18, 2019 |
| Days to Decision | 86 days |
| Submission Type | Special |
| 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 |