Atlas FDA

VAPOR-PHASE HEATED WIRE CONTROLLER

FDA 510(k) clearance K881137 · decided 1988-04-27

Clearance details

K-number
K881137
Device name
VAPOR-PHASE HEATED WIRE CONTROLLER
Applicant
Advanced Research Technologies, Inc.
Decision
Substantially Equivalent
Date received
1988-03-16
Decision date
1988-04-27
Days to decision
42 days
Clearance type
Traditional
Product code
BZE
Device class
2
Regulation number
868.5270
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Corinth, NY, US
Third-party review
No
Expedited review
No

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AirLife Adult Heated Wire BiPAP/NIV Circuit (K170378)Vyaire Medical2017-09-14
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Recalls involving this device

No recalls on record reference this clearance.