Device Classification Name |
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
|
510(k) Number |
K941252 |
Device Name |
RESPIRATORY AND CARDIAC SPECTRAL FREQUENCY SIGNAL PROCESSOR |
Applicant |
ANSAR |
242 SOUTH EIGHTH ST. |
PHILIDELPHIA,
PA
19107
|
|
Applicant Contact |
ROBERT G WELCH |
Correspondent |
ANSAR |
242 SOUTH EIGHTH ST. |
PHILIDELPHIA,
PA
19107
|
|
Correspondent Contact |
ROBERT G WELCH |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 03/15/1994 |
Decision Date | 09/20/1995 |
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
|
|
|