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FDA 510(k)

CapnoSpot™ Pneumothorax Decompression Indicator

N.º K: K223625 · 2023-03-28

SolicitantePneumeric, Inc.
Fecha de decisión2023-03-28
Código de productoGAA
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

CapnoSpot™ Pneumothorax Decompression Indicator is the device name listed in this FDA 510(k) record. The listed applicant is Pneumeric, Inc.. It received FDA 510(k) clearance on 2023-03-28 under 510(k) number K223625. The device is classified under product code GAA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CapnoSpot™ Pneumothorax Decompression Indicator?

CapnoSpot™ Pneumothorax Decompression Indicator is a medical device that received FDA 510(k) clearance on 2023-03-28. The listed applicant is Pneumeric, Inc.. The 510(k) number is K223625.

When did CapnoSpot™ Pneumothorax Decompression Indicator receive FDA 510(k) clearance?

CapnoSpot™ Pneumothorax Decompression Indicator received FDA 510(k) clearance on 2023-03-28, under 510(k) number K223625.

Who is the listed applicant for CapnoSpot™ Pneumothorax Decompression Indicator?

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

What is the FDA product code for CapnoSpot™ Pneumothorax Decompression Indicator?

The FDA product code for CapnoSpot™ Pneumothorax Decompression Indicator is GAA.

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Fuente oficial

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