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510(k) K000314

INCENTIVE SPIROMETER by Engineered Medical Systems — Product Code BWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2000
Date Received
February 1, 2000
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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