Atlas FDA

REPROCESSED MASIMO PULSE OXIMETER SENSORS

FDA 510(k) clearance K081238 · decided 2008-07-29

Clearance details

K-number
K081238
Device name
REPROCESSED MASIMO PULSE OXIMETER SENSORS
Applicant
Ascent Healthcare Solutions
Decision
Substantially Equivalent
Date received
2008-05-01
Decision date
2008-07-29
Days to decision
89 days
Clearance type
Traditional
Product code
NLF
Device class
2
Regulation number
870.2700
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Phoenix, AZ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.