Device Classification Name |
monitor, physiological, patient (without arrhythmia detection or alarms)
|
510(k) Number |
K004050 |
Device Name |
PANASONIC TELE-HOMECARE SYSTEM |
Applicant |
MATSUSHITA ELECTRIC INDUSTRIAL CO., LTD. |
1801 ROCKVILLE PIKE |
ROCKVILLE,
MD
20852
|
|
Applicant Contact |
DAVID L WEST |
Correspondent |
MATSUSHITA ELECTRIC INDUSTRIAL CO., LTD. |
1801 ROCKVILLE PIKE |
ROCKVILLE,
MD
20852
|
|
Correspondent Contact |
DAVID L WEST |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 12/29/2000 |
Decision Date | 03/15/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|