The following data is part of a premarket notification filed by Atom Medical Corp. with the FDA for Atom Infa Warmer V-505.
| Device ID | K002355 |
| 510k Number | K002355 |
| Device Name: | ATOM INFA WARMER V-505 |
| Classification | Warmer, Infant Radiant |
| Applicant | ATOM MEDICAL CORP. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Sheila Hemeon-heyer |
| Correspondent | Sheila Hemeon-heyer ATOM MEDICAL CORP. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-02 |
| Decision Date | 2000-10-10 |