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FDA 510(k)

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

K-Number: K162562 · 2017-03-17

ApplicantBcg Medical, LLC
Decision Date2017-03-17
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY is the device name listed in this FDA 510(k) record. The listed applicant is Bcg Medical, LLC. It received FDA 510(k) clearance on 2017-03-17 under 510(k) 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. The listed applicant is Bcg Medical, LLC. The 510(k) number is K162562.

When did OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY receive FDA 510(k) clearance?

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

Who is the listed applicant for OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY?

The FDA 510(k) record lists Bcg Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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