510(k) K992721

COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE by Radionics, Inc. — Product Code HAW

K992721 is an FDA 510(k) premarket notification submitted by Radionics, Inc. for the device "COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE". The FDA issued a decision of Substantially Equivalent on September 10, 1999. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Radionics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 1999
Date Received
August 13, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurological Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
NE
Submission Type