Device Classification Name |
Recorder, Paper Chart
|
510(k) Number |
K822978 |
Device Name |
MINGOGRAF 4, MINGO CARD 4 & MINOCARD 3 |
Applicant |
SIEMENS CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
SIEMENS CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 870.2810 |
Classification Product Code |
|
Date Received | 10/08/1982 |
Decision Date | 12/15/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|