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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30351688427247 | K991861 | 000 |
| 30351688427230 | K991861 | 000 |
| 30351688427223 | K991861 | 000 |
| 30351688427216 | K991861 | 000 |
| 30351688427209 | K991861 | 000 |
| 30351688427193 | K991861 | 000 |
| 30351688427186 | K991861 | 000 |
| 30351688427179 | K991861 | 000 |