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FDA 510(k)

MODEL 820 TOP=TRAK

K-Number: K873039 · 1988-02-11

ApplicantSierra Laboratories, Inc.
Decision Date1988-02-11
Product CodeBYN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODEL 820 TOP=TRAK is the device name listed in this FDA 510(k) record. The listed applicant is Sierra Laboratories, Inc.. It received FDA 510(k) clearance on 1988-02-11 under 510(k) number K873039. The device is classified under product code BYN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 820 TOP=TRAK?

MODEL 820 TOP=TRAK is a medical device that received FDA 510(k) clearance on 1988-02-11. The listed applicant is Sierra Laboratories, Inc.. The 510(k) number is K873039.

When did MODEL 820 TOP=TRAK receive FDA 510(k) clearance?

MODEL 820 TOP=TRAK received FDA 510(k) clearance on 1988-02-11, under 510(k) number K873039.

Who is the listed applicant for MODEL 820 TOP=TRAK?

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

What is the FDA product code for MODEL 820 TOP=TRAK?

The FDA product code for MODEL 820 TOP=TRAK is BYN.

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Other records listing Sierra Laboratories, Inc. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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