The following data is part of a premarket notification filed by Atom Medical Corp. with the FDA for V-2100g Advanced Infant Incubator.
| Device ID | K021809 |
| 510k Number | K021809 |
| Device Name: | V-2100G ADVANCED INFANT INCUBATOR |
| Classification | Incubator, Neonatal |
| 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 | FMZ |
| CFR Regulation Number | 880.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-03 |
| Decision Date | 2002-07-18 |
| Summary: | summary |