Device Classification Name |
transmitters and receivers, electrocardiograph, telephone
|
510(k) Number |
K971650 |
Device Name |
RHYTHMSTAT XL |
Applicant |
DATA CRITICAL CORP. |
9223 ILONA LN. |
HOUSTON,
TX
77025 -4218
|
|
Applicant Contact |
LISA S JONES |
Correspondent |
DATA CRITICAL CORP. |
9223 ILONA LN. |
HOUSTON,
TX
77025 -4218
|
|
Correspondent Contact |
LISA S JONES |
Regulation Number | 870.2920
|
Classification Product Code |
|
Date Received | 05/06/1997 |
Decision Date | 12/04/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|