VISENSIA


Device Classification Name

monitor, physiological, patient(with arrhythmia detection or alarms)

510(k) Number K081140
Device Name VISENSIA
Applicant
OBS MEDICAL
11495 pennsylvania st. ste.
250
carmel, 
IN 
46032

Applicant Contact wayne nethercutt
Correspondent
OBS MEDICAL
11495 pennsylvania st. ste.
250
carmel, 
IN 
46032

Correspodent Contact wayne nethercutt
Regulation Number 870.1025
Classification Product Code
MHX  
Date Received 04/22/2008
Decision Date 07/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No