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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilatory Effort Recorder
510(k) Number K242424
Device Name Bluebird Single-Use Respiratory Effort Belt
Applicant
Cadwell Industries, Inc.
909 N Kellogg St.
Kennewick,  WA  99336
Applicant Contact Jason Ford
Correspondent
Cadwell Industries, Inc.
909 N Kellogg St.
Kennewick,  WA  99336
Correspondent Contact Jason Ford
Regulation Number868.2375
Classification Product Code
MNR  
Date Received08/15/2024
Decision Date 12/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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