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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 K132168
Device Name BRONCHOSCOPY ELBOW
Applicant
Respironics, Inc.
365 Plum Industrial Court
Pittsburgh,  PA  15239
Applicant Contact COLLEEN WITT
Correspondent
Respironics, Inc.
365 Plum Industrial Court
Pittsburgh,  PA  15239
Correspondent Contact COLLEEN WITT
Regulation Number868.5905
Classification Product Code
BZD  
Date Received07/12/2013
Decision Date 11/20/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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