Atlas FDA

MASTERSCREEN & OXYCON CPX

FDA 510(k) clearance K072323 · decided 2007-10-10

Clearance details

K-number
K072323
Device name
MASTERSCREEN & OXYCON CPX
Applicant
Viasys Healthcare GmbH
Decision
Substantially Equivalent
Date received
2007-08-20
Decision date
2007-10-10
Days to decision
51 days
Clearance type
Special
Product code
BZC
Device class
2
Regulation number
868.1880
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Yorba Linda, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.