Atlas FDA

DATEX-OHMEDA OXY-AFR SENSOR

FDA 510(k) clearance K042891 · decided 2005-06-29

Clearance details

K-number
K042891
Device name
DATEX-OHMEDA OXY-AFR SENSOR
Applicant
Datex-Ohmeda
Decision
Substantially Equivalent
Date received
2004-10-19
Decision date
2005-06-29
Days to decision
253 days
Clearance type
Traditional
Product code
NLF
Device class
2
Regulation number
870.2700
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Needham, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.