FDA 510(k)

OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY

K-Number: K162562 · 2017-03-17

Decision Date2017-03-17

Product CodeDWJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY is a medical device manufactured by Bcg Medical, LLC. It received FDA 510(k) clearance on 2017-03-17 under approval number K162562. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY?

OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY is a medical device that received FDA 510(k) clearance on 2017-03-17. It is manufactured by Bcg Medical, LLC. The 510(k) number is K162562.

When was OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY approved by the FDA?

OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY received FDA 510(k) clearance on 2017-03-17, under approval number K162562.

What company makes OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY?

OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY is manufactured by Bcg Medical, LLC.

What is the FDA product code for OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY?

The FDA product code for OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY is DWJ.

Related Devices (Code: DWJ)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.