Device Classification Name |
meter, peak flow, spirometry
|
510(k) Number |
K050853 |
Device Name |
PMP4 SPIROPRO |
Applicant |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST. |
REHOVOT,
IL
76100
|
|
Applicant Contact |
NA'AMA OREN |
Correspondent |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST. |
REHOVOT,
IL
76100
|
|
Correspondent Contact |
NA'AMA OREN |
Regulation Number | 868.1860
|
Classification Product Code |
|
Date Received | 04/04/2005 |
Decision Date | 05/04/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|