The following data is part of a premarket notification filed by Medical Marketing Concepts with the FDA for Bagright Resuscitator.
| Device ID | K954296 |
| 510k Number | K954296 |
| Device Name: | BAGRIGHT RESUSCITATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | MEDICAL MARKETING CONCEPTS 20 BREEDEN COURT Hardy, VA 24101 |
| Contact | Bob Martin |
| Correspondent | Bob Martin MEDICAL MARKETING CONCEPTS 20 BREEDEN COURT Hardy, VA 24101 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-14 |
| Decision Date | 1995-12-20 |