FDA 510(k)

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

N.º K: K162562 · 2017-03-17

Fecha de decisión2017-03-17

Código de productoDWJ

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Fuente oficial

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