Device Classification Name |
detector and alarm, arrhythmia
|
510(k) Number |
K090037 |
FOIA Releasable 510(k) |
K090037
|
Device Name |
MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG |
Applicant |
MEDICALGORITHMICS SP Z.O.O. |
245 WEST 107TH STREET |
SUITE 11A |
NEW YORK,
NY
10025
|
|
Applicant Contact |
MARTIN JASINSKI |
Correspondent |
MEDICALGORITHMICS SP Z.O.O. |
245 WEST 107TH STREET |
SUITE 11A |
NEW YORK,
NY
10025
|
|
Correspondent Contact |
MARTIN JASINSKI |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 01/06/2009 |
Decision Date | 05/22/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|