VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY


Device Classification Name

recorder, magnetic tape, medical

510(k) Number K111180
Device Name VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY
Applicant
VASOMEDICAL, INC.
180 linden ave.
westbury, 
NY 
11590

Applicant Contact richard e gordon
Correspondent
VASOMEDICAL, INC.
180 linden ave.
westbury, 
NY 
11590

Correspodent Contact richard e gordon
Regulation Number 870.2800
Classification Product Code
DSH  
Date Received 04/27/2011
Decision Date 06/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No