
Optim, LLC
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ENTity WiFi Video Nasopharyngoscope System is an FDA 510(k)-cleared medical device (K200609) manufactured by Optim, LLC. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 12, 2021. Regulation: 8.

Ansell
SKU MSC846624

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SKU K014192

McKesson
SKU VM-1270030

Hollister
SKU VM-1270031