The following data is part of a premarket notification filed by Sims Portex, Inc. with the FDA for Ist Response Manual Resuscitator, Models, 008000, 008003,008006.
| Device ID | K992057 |
| 510k Number | K992057 |
| Device Name: | IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006 |
| 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 | 1999-06-18 |
| Decision Date | 1999-09-13 |
| Summary: | summary |