510(k) K032833
K032833 is an FDA 510(k) premarket notification submitted by Otto Bock Healthcare LP for the device "MYOSYSTEM WITH CUSTOMIZING". The FDA issued a decision of Substantially Equivalent on September 23, 2003. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Otto Bock Healthcare LP has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 2003
- Date Received
- September 11, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Cutaneous
- Device Class
- Class II
- Regulation Number
- 882.1320
- Review Panel
- NE
- Submission Type