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 |