Obsidio, Inc.

GEM

Name: GEM
Brand: Obsidio, Inc.
SKU: K213385

SKU K213385UPC KRD

In Stock

—

IIFDA 510(k) Cleared (K213385)

1

Free shipping on orders over $99 · 30-day returns

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Obsidio, Inc.

GEM

SKU K213385UPC KRD

In Stock

—

IIFDA 510(k) Cleared (K213385)

1

Free shipping on orders over $99 · 30-day returns

GEM is an FDA 510(k)-cleared medical device (K213385) manufactured by Obsidio, 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 June 30, 2022. Regulation: 8.