Atlas FDA

M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS

FDA 510(k) clearance K110723 · decided 2011-07-28

Clearance details

K-number
K110723
Device name
M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS
Applicant
Masimo Corporation
Decision
Substantially Equivalent
Date received
2011-03-16
Decision date
2011-07-28
Days to decision
134 days
Clearance type
Special
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.