
Solaris Medical Technology, Inc.
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SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES is an FDA 510(k)-cleared medical device (K092950) manufactured by Solaris Medical Technology, 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 March 11, 2010. Regulation: 8.