
Edentec Corp.
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EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. is an FDA 510(k)-cleared medical device (K893561) manufactured by Edentec Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 24, 1989. Regulation: 8.

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