FDA 510(k)

HALO AP Dx

K-Nummer: K232833 · 2024-05-07

Entscheidungsdatum2024-05-07

ProduktcodePSY

BeratungsausschussPA

EntscheidungSubstantially Equivalent

Produktübersicht

HALO AP Dx is the device name listed in this FDA 510(k) record. The listed applicant is Indica Labs, Inc.. It received FDA 510(k) clearance on 2024-05-07 under 510(k) number K232833. The device is classified under product code PSY. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the HALO AP Dx?

HALO AP Dx is a medical device that received FDA 510(k) clearance on 2024-05-07. The listed applicant is Indica Labs, Inc.. The 510(k) number is K232833.

When did HALO AP Dx receive FDA 510(k) clearance?

HALO AP Dx received FDA 510(k) clearance on 2024-05-07, under 510(k) number K232833.

Who is the listed applicant for HALO AP Dx?

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

What is the FDA product code for HALO AP Dx?

The FDA product code for HALO AP Dx is PSY.

Verwandte Geräte (Code: PSY)

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