510(k) K051397
K051397 is an FDA 510(k) premarket notification submitted by Biobands Distributors, Inc. for the device "BIOBANDS". The FDA issued a decision of Substantially Equivalent on Sep 16, 2005. The device falls under product code MVV (Device, Acupressure), a Class U device.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 16, 2005
- Date Received
- May 27, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Device, Acupressure
- Device Class
- Class U
- Review Panel
- NE
- Submission Type
- Enforcement Discretion