The following data is part of a premarket notification filed by Medical Measurement Systems,b.v. with the FDA for Mms Video Option.
Device ID | K050993 |
510k Number | K050993 |
Device Name: | MMS VIDEO OPTION |
Classification | System, Image Processing, Radiological |
Applicant | MEDICAL MEASUREMENT SYSTEMS,B.V. COLOSSEUM 25 Enschede, NL 7521 Pv |
Contact | Karin Ogink-somhorst |
Correspondent | Karin Ogink-somhorst MEDICAL MEASUREMENT SYSTEMS,B.V. COLOSSEUM 25 Enschede, NL 7521 Pv |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-04-19 |
Decision Date | 2005-05-26 |