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647
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505
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497
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510k Database
Manufacturers
IL
Orsense, Ltd.
Medical Device Manufacturer
·
IL , Kfar Saba
Orsense, Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2010
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Orsense, Ltd.
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 16, 2015
Pulse oximeter NBM-200
K142209
·
DQA
Anesthesiology
·
158d
Cleared
Oct 17, 2013
NBM-200MP
K124041
·
DQA
Anesthesiology
·
293d
Cleared
Mar 19, 2010
NBM-200MP PULSE OXIMETRY DEVICE
K091564
·
DQA
Anesthesiology
·
295d
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Anesthesiology
3