Device Classification Name |
recorder, magnetic tape, medical
|
510(k) Number |
K930894 |
Device Name |
MULTITRAK-PLUS |
Applicant |
ZYMED MEDICAL INSTRUMENTATION |
20 NORTH AVIADOR ST. |
CAMARILLO,
CA
93010
|
|
Applicant Contact |
HOSMEL GALAN |
Correspondent |
ZYMED MEDICAL INSTRUMENTATION |
20 NORTH AVIADOR ST. |
CAMARILLO,
CA
93010
|
|
Correspondent Contact |
HOSMEL GALAN |
Regulation Number | 870.2800
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/22/1993 |
Decision Date | 11/01/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|