510(k) K042208
K042208 is an FDA 510(k) premarket notification submitted by Inomed Medizintechnik GmbH for the device "ISIS MER SYSTEM/ELEKTA MER SYSTEM". The FDA issued a decision of Substantially Equivalent on March 18, 2005. The device falls under product code GZL (Electrode, Depth), a Class II device regulated under 21 CFR 882.1330. Inomed Medizintechnik GmbH has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 18, 2005
- Date Received
- August 16, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Depth
- Device Class
- Class II
- Regulation Number
- 882.1330
- Review Panel
- NE
- Submission Type