Device Classification Name |
Device, Biofeedback
|
510(k) Number |
K020399 |
FOIA Releasable 510(k) |
K020399
|
Device Name |
RESPERATE; MODEL RR-150 |
Applicant |
INTERCURE LTD. |
555 13TH ST. N.W. |
WASHINGTON,
DC
20004 -1109
|
|
Applicant Contact |
JONATHAN S KAHAN |
Correspondent |
INTERCURE LTD. |
555 13TH ST. N.W. |
WASHINGTON,
DC
20004 -1109
|
|
Correspondent Contact |
JONATHAN S KAHAN |
Regulation Number | 882.5050
|
Classification Product Code |
|
Date Received | 02/06/2002 |
Decision Date | 07/02/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|