Device Classification Name |
electrode, electrocardiograph
|
510(k) Number |
K930312 |
Device Name |
3M RED DOT 2234 RADIOLUCENT MONITORING ELECTRODE |
Applicant |
3M HEALTH CARE, LTD. |
3M CENTER, BLDG. 275-3E-08 |
P.O. BOX 33275 |
ST. PAUL,
MN
55133
|
|
Applicant Contact |
JULIA L WANNAMAKER |
Correspondent |
3M HEALTH CARE, LTD. |
3M CENTER, BLDG. 275-3E-08 |
P.O. BOX 33275 |
ST. PAUL,
MN
55133
|
|
Correspondent Contact |
JULIA L WANNAMAKER |
Regulation Number | 870.2360
|
Classification Product Code |
|
Date Received | 01/22/1993 |
Decision Date | 09/01/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|