The following data is part of a premarket notification filed by Dresser Argus, Inc. with the FDA for Dresser Argus P/n 1818.
Device ID | K905304 |
510k Number | K905304 |
Device Name: | DRESSER ARGUS P/N 1818 |
Classification | Ventilator, Emergency, Manual (resuscitator) |
Applicant | DRESSER ARGUS, INC. 36 BRIDGE ST. Brooklyn, NY 11201 |
Contact | Warren Frank |
Correspondent | Warren Frank DRESSER ARGUS, INC. 36 BRIDGE ST. Brooklyn, NY 11201 |
Product Code | BTM |
CFR Regulation Number | 868.5915 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-28 |
Decision Date | 1991-04-17 |