NERVUS MONITOR


Device Classification Name

standard polysomnograph with electroencephalograph

510(k) Number K021185
Device Name NERVUS MONITOR
Original Applicant
TAUGAGREINING HF
po box 4341
crofton, 
MD 
21114

Original Contact e.j. smith
Regulation Number 882.1400
Classification Product Code
OLV  
Subsequent Product Code
GWQ  
Date Received 04/15/2002
Decision Date 07/12/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls