The following data is part of a premarket notification filed by Mag, Inc. with the FDA for M.a.g. Inc. Brealthing Bags.
| Device ID | K942134 |
| 510k Number | K942134 |
| Device Name: | M.A.G. INC. BREALTHING BAGS |
| Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| Applicant | MAG, INC. 30 ROBB HILL RD. Martinsville, IN 46151 |
| Contact | Rob Fye |
| Correspondent | Rob Fye MAG, INC. 30 ROBB HILL RD. Martinsville, IN 46151 |
| Product Code | CAI |
| CFR Regulation Number | 868.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-03 |
| Decision Date | 1994-06-22 |