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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K802847
Device Name OXYGEN SATURATION METER MODEL NO. SM-1
Applicant
Bentley Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Bentley Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Date Received11/12/1980
Decision Date 12/16/1980
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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