The following data is part of a premarket notification filed by Neoforce Group, Inc. with the FDA for Ispira Resuscitation Unit.
| Device ID | K092085 |
| 510k Number | K092085 |
| Device Name: | ISPIRA RESUSCITATION UNIT |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | NEOFORCE GROUP, INC. 35 COMMERCE DR. Ivyland, PA 18974 |
| Contact | Monica Ferrante |
| Correspondent | Monica Ferrante NEOFORCE GROUP, INC. 35 COMMERCE DR. Ivyland, PA 18974 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-09 |
| Decision Date | 2009-10-07 |
| Summary: | summary |