The following data is part of a premarket notification filed by Neoforce Group, Inc. with the FDA for V-2200 Infant Incubator.
| Device ID | K061280 |
| 510k Number | K061280 |
| Device Name: | V-2200 INFANT INCUBATOR |
| Classification | Incubator, Neonatal |
| Applicant | NEOFORCE GROUP, INC. 5985 HONEY HOLLOW RD. Doylestown, PA 18901 |
| Contact | Mary Staniewicz |
| Product Code | FMZ |
| CFR Regulation Number | 880.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-05-08 |
| Decision Date | 2006-06-27 |
| Summary: | summary |