Device Classification Name |
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
|
510(k) Number |
K944495 |
Device Name |
MODEL 3200 VASCULAR MINI-LAB |
Applicant |
PARKS MEDICAL ELECTRONICS, INC. |
P.O. BOX 5669 |
ALOHA,
OR
97006
|
|
Applicant Contact |
LARRY D SMURTHWAITE |
Correspondent |
PARKS MEDICAL ELECTRONICS, INC. |
P.O. BOX 5669 |
ALOHA,
OR
97006
|
|
Correspondent Contact |
LARRY D SMURTHWAITE |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 09/13/1994 |
Decision Date | 06/02/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|