The following data is part of a premarket notification filed by Christine Valmy Inc with the FDA for Ohmniscan Ng.
Device ID | K073334 |
510k Number | K073334 |
Device Name: | OHMNISCAN NG |
Classification | Analyzer, Body Composition |
Applicant | CHRISTINE VALMY INC 285, CHANGE BRIDGE ROAD Pine Brook, NJ 07058 |
Contact | Peter Dehaydu |
Correspondent | Peter Dehaydu CHRISTINE VALMY INC 285, CHANGE BRIDGE ROAD Pine Brook, NJ 07058 |
Product Code | MNW |
CFR Regulation Number | 870.2770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-11-28 |
Decision Date | 2008-08-22 |
Summary: | summary |