The following data is part of a premarket notification filed by Neoforce Group, Inc. with the FDA for Neopop Infant Resuscitator With Flow Meter.
| Device ID | K102649 |
| 510k Number | K102649 |
| Device Name: | NEOPOP INFANT RESUSCITATOR WITH FLOW METER |
| 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 | 2010-09-14 |
| Decision Date | 2011-01-06 |
| Summary: | summary |