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510(k) K893665

AEROSOL INHALATION MONITOR by Vitalograph , Ltd. — Product Code BWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1989
Date Received
May 15, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Therapeutic (Incentive)
Device Class
Class II
Regulation Number
868.5690
Review Panel
AN
Submission Type

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  • K912412 — VITALOGRAPH SPIROTRAC III (October 15, 1991)

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