The following data is part of a premarket notification filed by International Biomedical with the FDA for Lifeborne Infant Resuscitator.
| Device ID | K140707 |
| 510k Number | K140707 |
| Device Name: | LIFEBORNE INFANT RESUSCITATOR |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | INTERNATIONAL BIOMEDICAL 8206 CROSS PARK DR. Austin, TX 78754 |
| Contact | Amy Pieper |
| Correspondent | Amy Pieper INTERNATIONAL BIOMEDICAL 8206 CROSS PARK DR. Austin, TX 78754 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-20 |
| Decision Date | 2014-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868406000051 | K140707 | 000 |