510(k) K913604
K913604 is an FDA 510(k) premarket notification submitted by Biomagnetic Technologies, Inc. for the device "SOMATOSENSORY STIMULUS SYSTEM". The FDA issued a decision of Substantially Equivalent on December 9, 1991. The device falls under product code GZP (Stimulator, Mechanical, Evoked Response), a Class II device regulated under 21 CFR 882.1880. Biomagnetic Technologies, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 1991
- Date Received
- August 14, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Mechanical, Evoked Response
- Device Class
- Class II
- Regulation Number
- 882.1880
- Review Panel
- NE
- Submission Type