Device Classification Name |
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
|
510(k) Number |
K914576 |
Device Name |
KELLER CARDIAC MONITOR MEDIL KMS870 |
Applicant |
KELLER MEDICAL SPECIALTIES PRODUCTS, INC. |
42609 CRAWFORD RD. |
ANTIOCH,
IL
60002
|
|
Applicant Contact |
JAY KELLER |
Correspondent |
KELLER MEDICAL SPECIALTIES PRODUCTS, INC. |
42609 CRAWFORD RD. |
ANTIOCH,
IL
60002
|
|
Correspondent Contact |
JAY KELLER |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 10/15/1991 |
Decision Date | 12/30/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|