Atlas FDA

HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II

FDA 510(k) clearance K012715 · decided 2003-08-01

Clearance details

K-number
K012715
Device name
HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II
Applicant
Hygia Health Services, Inc.
Decision
Substantially Equivalent
Date received
2001-08-14
Decision date
2003-08-01
Days to decision
717 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.