The following data is part of a premarket notification filed by Mag, Inc. with the FDA for M.a.g. Inc. Hyperinflation System.
Device ID | K942132 |
510k Number | K942132 |
Device Name: | M.A.G. INC. HYPERINFLATION SYSTEM |
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 |