The following data is part of a premarket notification filed by Merced Medical, Inc. with the FDA for Cpr Bag.
Device ID | K911622 |
510k Number | K911622 |
Device Name: | CPR 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 | 1991-04-11 |
Decision Date | 1991-05-20 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CPR BAG 74460415 not registered Dead/Abandoned |
MERCURY ENTERPRISES, INC. 1993-11-19 |