
Hygia Health Services, Inc.
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HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II is an FDA 510(k)-cleared medical device (K012715) manufactured by Hygia Health Services, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 31, 2003. Regulation: 8.