Device Classification Name |
monitor, physiological, patient(with arrhythmia detection or alarms)
|
510(k) Number |
K013311 |
Device Name |
MODIFICATION TO: POCKETVIEW ECG SOFTWARE |
Applicant |
MICROMEDICAL INDUSTRIES, LTD. |
11 TECHNOLOGY DR. |
LABRADOR QUEENSLAND,
AU
4215
|
|
Applicant Contact |
STEPHEN CRESSWELL |
Correspondent |
MICROMEDICAL INDUSTRIES, LTD. |
11 TECHNOLOGY DR. |
LABRADOR QUEENSLAND,
AU
4215
|
|
Correspondent Contact |
STEPHEN CRESSWELL |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 10/04/2001 |
Decision Date | 01/03/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|