The following data is part of a premarket notification filed by Merced Medical, Inc. with the FDA for Mer Bag.
| Device ID | K915810 |
| 510k Number | K915810 |
| Device Name: | MER BAG |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | MERCED MEDICAL, INC. 113300 A-49TH ST. NORTH Clearwater, FL 34622 |
| Contact | Jeff Ratner |
| Correspondent | Jeff Ratner MERCED MEDICAL, INC. 113300 A-49TH ST. NORTH Clearwater, FL 34622 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-24 |
| Decision Date | 1992-03-09 |