Atlas FDA

COBE AIR EMBOLI PROTECTION SYSTEM (AEPS)

FDA 510(k) clearance K900910 · decided 1990-05-22

Clearance details

K-number
K900910
Device name
COBE AIR EMBOLI PROTECTION SYSTEM (AEPS)
Applicant
Cobe Laboratories, Inc.
Decision
Substantially Equivalent
Date received
1990-02-27
Decision date
1990-05-22
Days to decision
84 days
Clearance type
Traditional
Product code
DTW
Device class
2
Regulation number
870.4340
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Lakewood, CO, US
Third-party review
No
Expedited review
No

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SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL (K900815)3M Company1990-05-09
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GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200 (K860076)Gambro, Inc.1986-05-30
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Recalls involving this device

No recalls on record reference this clearance.