510(k) K101889
K101889 is an FDA 510(k) premarket notification submitted by Pivotal Health Solutions for the device "DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE". The FDA issued a decision of Substantially Equivalent on August 27, 2010. The device falls under product code ITH (Equipment, Traction, Powered), a Class II device regulated under 21 CFR 890.5900. Pivotal Health Solutions has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 2010
- Date Received
- July 7, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Equipment, Traction, Powered
- Device Class
- Class II
- Regulation Number
- 890.5900
- Review Panel
- PM
- Submission Type