Device Classification Name |
transmitters and receivers, electrocardiograph, telephone
|
510(k) Number |
K900541 |
Device Name |
LIFE-TEL CELLULAR TRANSCEIVER |
Applicant |
RACOM, INC. |
5504 STATE RD. |
CLEVELAND,
OH
44134
|
|
Applicant Contact |
ERIN SULLIVAN |
Correspondent |
RACOM, INC. |
5504 STATE RD. |
CLEVELAND,
OH
44134
|
|
Correspondent Contact |
ERIN SULLIVAN |
Regulation Number | 870.2920
|
Classification Product Code |
|
Date Received | 02/05/1990 |
Decision Date | 07/13/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|