The following data is part of a premarket notification filed by Atom Medical Inc with the FDA for V-505 Infa Warmer.
| Device ID | K060461 |
| 510k Number | K060461 |
| Device Name: | V-505 INFA WARMER |
| Classification | Warmer, Infant Radiant |
| Applicant | ATOM MEDICAL INC IWAKATA BLDG 3RD FLOOR 3-18-15 HUNGO Tokoyo, JP 1130033 |
| Contact | Mary Staniewicz |
| Correspondent | Mary Staniewicz ATOM MEDICAL INC IWAKATA BLDG 3RD FLOOR 3-18-15 HUNGO Tokoyo, JP 1130033 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-22 |
| Decision Date | 2006-04-28 |
| Summary: | summary |