PC ECG 1200


information about

Device Classification Name

monitor,physiological,patient(without arrhythmia detection or alarms)

510(k) Number K000404
Device Name PC ECG 1200
Original Applicant
NORAV MEDICAL LTD.
12505 58th ave. n.
plymouth, 
MN 
55442

Original Contact steve springrose
Regulation Number 870.2300
Classification Product Code
MWI  
Date Received 02/07/2000
Decision Date 11/22/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No