510(k) K880773
K880773 is an FDA 510(k) premarket notification submitted by Neuroscientific Corp. for the device "THE VENUS SYSTEM". The FDA issued a decision of Substantially Equivalent on August 18, 1988. The device falls under product code GWL (Amplifier, Physiological Signal), a Class II device regulated under 21 CFR 882.1835. Neuroscientific Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 1988
- Date Received
- February 26, 1988
- 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