510(k) K050993
K050993 is an FDA 510(k) premarket notification submitted by Medical Measurement Systems B.V. for the device "MMS VIDEO OPTION". The FDA issued a decision of Substantially Equivalent on May 26, 2005. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Medical Measurement Systems B.V. has 6 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 26, 2005
- Date Received
- Apr 19, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type
- 510(k)