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FDA 510(k)

ROKONICS SENTRY MODEL 8500

K-Number: K851819 · 1986-01-21

ApplicantRokonics, Inc.
Decision Date1986-01-21
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ROKONICS SENTRY MODEL 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 1986-01-21 under 510(k) number K851819. 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 SENTRY MODEL 8500?

ROKONICS SENTRY MODEL 8500 is a medical device that received FDA 510(k) clearance on 1986-01-21. The listed applicant is Rokonics, Inc.. The 510(k) number is K851819.

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

ROKONICS SENTRY MODEL 8500 received FDA 510(k) clearance on 1986-01-21, under 510(k) number K851819.

Who is the listed applicant for ROKONICS SENTRY MODEL 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 SENTRY MODEL 8500?

The FDA product code for ROKONICS SENTRY MODEL 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.

K871576ROKONICS 8500

Related Devices (Code: BZQ)

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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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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