The following data is part of a premarket notification filed by Neoforce Group, Inc. with the FDA for Neopeep Neonatal Resuscitation Circuit With Peep.
| Device ID | K070416 |
| 510k Number | K070416 |
| Device Name: | NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | NEOFORCE GROUP, INC. 35 COMMERCE DR. Ivyland, PA 18974 |
| Contact | Mary Staniewicz |
| Correspondent | Mary Staniewicz NEOFORCE GROUP, INC. 35 COMMERCE DR. Ivyland, PA 18974 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-12 |
| Decision Date | 2007-05-29 |
| Summary: | summary |