The following data is part of a premarket notification filed by Neoforce Group, Inc. with the FDA for Neopip Infant Resuscitator.
| Device ID | K072021 |
| 510k Number | K072021 |
| Device Name: | NEOPIP INFANT RESUSCITATOR |
| Classification | Ventilator, Emergency, Manual (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 | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-23 |
| Decision Date | 2007-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854401006396 | K072021 | 000 |
| 00854401006389 | K072021 | 000 |
| 05055931119593 | K072021 | 000 |
| 05055931119586 | K072021 | 000 |