510(k) K942926
K942926 is an FDA 510(k) premarket notification submitted by Burke Neutech, Inc. for the device "NEURO-AIDE". The FDA issued a decision of Substantially Equivalent on Aug 3, 1994. The device falls under product code GWY (Pinwheel), a Class I device regulated under 21 CFR 882.1750. Burke Neutech, Inc. has 6 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 3, 1994
- Date Received
- Jun 22, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Pinwheel
- Device Class
- Class I
- Regulation Number
- 882.1750
- Review Panel
- NE
- Submission Type
- 510(k) Exempt