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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K972614
Device Name TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI MODEL 605
Applicant
HEALTHDYNE TECHNOLOGIES, INC.
1255 KENNESTONE CIR.
MARIETTA,  GA  30066
Applicant Contact BETSY CORTELLONI
Correspondent
HEALTHDYNE TECHNOLOGIES, INC.
1255 KENNESTONE CIR.
MARIETTA,  GA  30066
Correspondent Contact BETSY CORTELLONI
Regulation Number868.5440
Classification Product Code
CAW  
Date Received07/14/1997
Decision Date 01/20/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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