The following data is part of a premarket notification filed by Sims Portex, Inc. with the FDA for 1st Response Infant Manual Resuscitator, Bag Resevoir, 1st Response Pediatric Manual Resuscitator, Bag Reservoir, 1st Re.
Device ID | K991861 |
510k Number | K991861 |
Device Name: | 1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE |
Classification | Ventilator, Emergency, Manual (resuscitator) |
Applicant | SIMS PORTEX, INC. 10 BOWMAN DR. Keene, NH 03431 |
Contact | Timothy J Talcott |
Correspondent | Timothy J Talcott SIMS PORTEX, INC. 10 BOWMAN DR. Keene, NH 03431 |
Product Code | BTM |
CFR Regulation Number | 868.5915 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-06-01 |
Decision Date | 2000-01-18 |
Summary: | summary |