The following data is part of a premarket notification filed by International Biomedical with the FDA for Puffin Lite Infant Resuscitation System.
| Device ID | K182956 |
| 510k Number | K182956 |
| Device Name: | Puffin Lite Infant Resuscitation System |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | International Biomedical 8206 Cross Park Drive Austin, TX 78754 |
| Contact | Amy Pieper |
| Correspondent | Amy Pieper International Biomedical 8206 Cross Park Drive Austin, TX 78754 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-24 |
| Decision Date | 2019-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00865648000344 | K182956 | 000 |