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510(k) K921387

BIRD 8400ST ADULT VOLUME VENTILATOR by Bird Products Corp. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1993
Date Received
March 23, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

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