Atlas FDA

PROLONG

FDA 510(k) clearance K081864 · decided 2008-09-25

Clearance details

K-number
K081864
Device name
PROLONG
Applicant
Life-Tech, Inc.
Decision
Substantially Equivalent
Date received
2008-07-01
Decision date
2008-09-25
Days to decision
86 days
Clearance type
Special
Product code
BSP
Device class
2
Regulation number
868.5150
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Stafford, TX, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.