Device Classification Name |
Oximeter
|
510(k) Number |
K091564 |
Device Name |
NBM-200MP PULSE OXIMETRY DEVICE |
Applicant |
ORSENSE LTD |
20 HATA'AS ST |
KFAR SABA,
IL
44425
|
|
Applicant Contact |
AHAVA STEIN |
Correspondent |
ORSENSE LTD |
20 HATA'AS ST |
KFAR SABA,
IL
44425
|
|
Correspondent Contact |
AHAVA STEIN |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 05/28/2009 |
Decision Date | 03/19/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|