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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K221436
Device Name F&P 950 Accessory Breathing Circuit Kits
Applicant
Fisher & Paykel Healthcare, Ltd.
15 Maurice Paykel Pl., E. Tamaki
Auckland,  NZ 2013
Applicant Contact Reena Daken
Correspondent
Fisher & Paykel Healthcare, Ltd.
15 Maurice Paykel Pl., E. Tamaki
Auckland,  NZ 2013
Correspondent Contact Reena Daken
Regulation Number868.5905
Classification Product Code
BZD  
Date Received05/17/2022
Decision Date 06/29/2023
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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