The following data is part of a premarket notification filed by Medical Marketing Concepts with the FDA for Bagright Resposable Infant Resuscitator.
| Device ID | K961332 |
| 510k Number | K961332 |
| Device Name: | BAGRIGHT RESPOSABLE INFANT RESUSCITATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | MEDICAL MARKETING CONCEPTS 2310 YORK RD. Roanoke, VA 24015 |
| Contact | Bob Martin |
| Correspondent | Bob Martin MEDICAL MARKETING CONCEPTS 2310 YORK RD. Roanoke, VA 24015 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-08 |
| Decision Date | 1996-06-28 |