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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 K014074
Device Name HOFFRICHTER VECTOR, VECTOR PLUS, VECTOR BI-VEVEL, VECTOR BI-LEVEL PLUS, SCALAR, SCALAR PLUS; CPAP WITH HUMIDIFIER OPTION
Applicant
Hoffrichter GmbH
S65w35739 Piper Rd.
Egale,  WI  53119
Applicant Contact STEPHEN H GORSKI
Correspondent
Hoffrichter GmbH
S65w35739 Piper Rd.
Egale,  WI  53119
Correspondent Contact STEPHEN H GORSKI
Regulation Number868.5905
Classification Product Code
BZD  
Date Received12/10/2001
Decision Date 07/23/2003
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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