Device Classification Name |
computer, diagnostic, programmable
|
510(k) Number |
K955015 |
Device Name |
ZYMED HOLTER SCANNER MODEL 2010 |
Applicant |
ZYMED MEDICAL INSTRUMENTATION |
20 NORTH AVIADOR ST. |
CAMARILLO,
CA
93010
|
|
Applicant Contact |
JOHN DUDLEY HARRIS |
Correspondent |
ZYMED MEDICAL INSTRUMENTATION |
20 NORTH AVIADOR ST. |
CAMARILLO,
CA
93010
|
|
Correspondent Contact |
JOHN DUDLEY HARRIS |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 11/01/1995 |
Decision Date | 03/18/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|