Atlas FDA

MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE

FDA 510(k) clearance K101280 · decided 2010-10-07

Clearance details

K-number
K101280
Device name
MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE
Applicant
Midwest Reprocessing Center, LLC
Decision
Substantially Equivalent
Date received
2010-05-06
Decision date
2010-10-07
Days to decision
154 days
Clearance type
Traditional
Product code
NLF
Device class
2
Regulation number
870.2700
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Birmingham, AL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.