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FDA 510(k)

ROKONICS 8500

K-Number: K871576 · 1987-07-16

ApplicantRokonics, Inc.
Decision Date1987-07-16
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ROKONICS 8500 is the device name listed in this FDA 510(k) record. The listed applicant is Rokonics, Inc.. It received FDA 510(k) clearance on 1987-07-16 under 510(k) number K871576. 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 ROKONICS 8500?

ROKONICS 8500 is a medical device that received FDA 510(k) clearance on 1987-07-16. The listed applicant is Rokonics, Inc.. The 510(k) number is K871576.

When did ROKONICS 8500 receive FDA 510(k) clearance?

ROKONICS 8500 received FDA 510(k) clearance on 1987-07-16, under 510(k) number K871576.

Who is the listed applicant for ROKONICS 8500?

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

What is the FDA product code for ROKONICS 8500?

The FDA product code for ROKONICS 8500 is BZQ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Rokonics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K851819ROKONICS SENTRY MODEL 8500

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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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