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FDA 510(k)

SLEEPTRACE 2000

K-Number: K911874 · 1992-06-25

ApplicantAreca Science Corp.
Decision Date1992-06-25
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SLEEPTRACE 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Areca Science Corp.. It received FDA 510(k) clearance on 1992-06-25 under 510(k) number K911874. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLEEPTRACE 2000?

SLEEPTRACE 2000 is a medical device that received FDA 510(k) clearance on 1992-06-25. The listed applicant is Areca Science Corp.. The 510(k) number is K911874.

When did SLEEPTRACE 2000 receive FDA 510(k) clearance?

SLEEPTRACE 2000 received FDA 510(k) clearance on 1992-06-25, under 510(k) number K911874.

Who is the listed applicant for SLEEPTRACE 2000?

The FDA 510(k) record lists Areca Science Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SLEEPTRACE 2000?

The FDA product code for SLEEPTRACE 2000 is BZQ.

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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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