| Device Classification Name |
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
|
| 510(k) Number |
K840524 |
| Device Name |
SERVOMED BASIC BEDSIDE UNIT SMV 110TP |
| Applicant |
| Litton Medical Electronics |
| 777 Nicholas Blvd. |
|
Elk Grove Village,
IL
60007
|
|
| Applicant Contact |
ROBERT L CASARSA |
| Correspondent |
| Litton Medical Electronics |
| 777 Nicholas Blvd. |
|
Elk Grove Village,
IL
60007
|
|
| Correspondent Contact |
ROBERT L CASARSA |
| Regulation Number | 870.2300 |
| Classification Product Code |
|
| Date Received | 02/07/1984 |
| Decision Date | 10/26/1984 |
| 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
|
|
|