510(k) K083322
K083322 is an FDA 510(k) premarket notification submitted by Neurometrix, Inc. for the device "NEUROMETRIX BIOAMPLIFIER". The FDA issued a decision of Substantially Equivalent on May 27, 2009. The device falls under product code GWL (Amplifier, Physiological Signal), a Class II device regulated under 21 CFR 882.1835. Neurometrix, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 27, 2009
- Date Received
- November 12, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Amplifier, Physiological Signal
- Device Class
- Class II
- Regulation Number
- 882.1835
- Review Panel
- NE
- Submission Type