The following data is part of a premarket notification filed by Atom Medical Corporation with the FDA for Neo-servo I.
| Device ID | K102710 |
| 510k Number | K102710 |
| Device Name: | NEO-SERVO I |
| Classification | Incubator, Neonatal |
| Applicant | ATOM MEDICAL CORPORATION 24301 WOODSTAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden ATOM MEDICAL CORPORATION 24301 WOODSTAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | FMZ |
| CFR Regulation Number | 880.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-20 |
| Decision Date | 2010-12-22 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NEO-SERVO I 79101016 not registered Dead/Abandoned |
Atom Medical Corporation 2011-04-06 |
![]() NEO-SERVO I 79096061 not registered Dead/Abandoned |
Atom Medical Corporation 2011-02-21 |