510(k) K901797
K901797 is an FDA 510(k) premarket notification submitted by Micro Tronics Corp. for the device "THE WONDER BOX". The FDA issued a decision of Substantially Equivalent on February 7, 1991. The device falls under product code GWL (Amplifier, Physiological Signal), a Class II device regulated under 21 CFR 882.1835. Micro Tronics Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 1991
- Date Received
- April 19, 1990
- 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