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FDA 510(k)

BAY AREA HYPERSCIENCES

K-Number: K030713 · 2003-12-19

ApplicantBay Area Hypersciences, LLC
Decision Date2003-12-19
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BAY AREA HYPERSCIENCES is the device name listed in this FDA 510(k) record. The listed applicant is Bay Area Hypersciences, LLC. It received FDA 510(k) clearance on 2003-12-19 under 510(k) number K030713. The device is classified under product code CBF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAY AREA HYPERSCIENCES?

BAY AREA HYPERSCIENCES is a medical device that received FDA 510(k) clearance on 2003-12-19. The listed applicant is Bay Area Hypersciences, LLC. The 510(k) number is K030713.

When did BAY AREA HYPERSCIENCES receive FDA 510(k) clearance?

BAY AREA HYPERSCIENCES received FDA 510(k) clearance on 2003-12-19, under 510(k) number K030713.

Who is the listed applicant for BAY AREA HYPERSCIENCES?

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

What is the FDA product code for BAY AREA HYPERSCIENCES?

The FDA product code for BAY AREA HYPERSCIENCES is CBF.

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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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