The following data is part of a premarket notification filed by Atom Medical Inc with the FDA for V-808 Atom Transcapsule.
| Device ID | K061071 |
| 510k Number | K061071 |
| Device Name: | V-808 ATOM TRANSCAPSULE |
| Classification | Incubator, Neonatal Transport |
| Applicant | ATOM MEDICAL INC 35 COMMERCE DRIVE Ivyland, PA 18974 |
| Contact | Mary Staniewicz |
| Correspondent | Mary Staniewicz ATOM MEDICAL INC 35 COMMERCE DRIVE Ivyland, PA 18974 |
| Product Code | FPL |
| CFR Regulation Number | 880.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-17 |
| Decision Date | 2006-08-29 |
| Summary: | summary |