Atlas FDA

LNCS OXIMETRY SENSORS

FDA 510(k) clearance K083719 · decided 2009-07-30

Clearance details

K-number
K083719
Device name
LNCS OXIMETRY SENSORS
Applicant
Masimo Corporation
Decision
Substantially Equivalent
Date received
2008-12-15
Decision date
2009-07-30
Days to decision
227 days
Clearance type
Traditional
Product code
NLF
Device class
2
Regulation number
870.2700
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Irvine, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.