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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixer, Breathing Gases, Anesthesia Inhalation
510(k) Number K090781
Device Name HELIO2 BLENDER
Applicant
PRECISION MEDICAL, INC.
300 HELD DR.
NORTHAMPTON,  PA  18067
Applicant Contact JAMES PARKER
Correspondent
PRECISION MEDICAL, INC.
300 HELD DR.
NORTHAMPTON,  PA  18067
Correspondent Contact JAMES PARKER
Regulation Number868.5330
Classification Product Code
BZR  
Date Received03/23/2009
Decision Date 08/13/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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