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Amco International Manufacturing & Design, Inc.
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AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A is an FDA 510(k)-cleared medical device (K091548) manufactured by Amco International Manufacturing & Design, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on August 6, 2009. Regulation: 8.