The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Multidiagnost Eleva.
Device ID | K050151 |
510k Number | K050151 |
Device Name: | MULTIDIAGNOST ELEVA |
Classification | System, X-ray, Stationary |
Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 22100 BOTHELL EVERETT HWY P.O. BOX 3003 Bothell, WA 98021 -8431 |
Contact | Lynn Harmer |
Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
Product Code | KPR |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2005-01-24 |
Decision Date | 2005-02-09 |
Summary: | summary |