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FDA 510(k)

OLLI 565

K-Number: K820540 · 1982-04-01

ApplicantKone Instruments, Inc.
Decision Date1982-04-01
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OLLI 565 is the device name listed in this FDA 510(k) record. The listed applicant is Kone Instruments, Inc.. It received FDA 510(k) clearance on 1982-04-01 under 510(k) number K820540. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLLI 565?

OLLI 565 is a medical device that received FDA 510(k) clearance on 1982-04-01. The listed applicant is Kone Instruments, Inc.. The 510(k) number is K820540.

When did OLLI 565 receive FDA 510(k) clearance?

OLLI 565 received FDA 510(k) clearance on 1982-04-01, under 510(k) number K820540.

Who is the listed applicant for OLLI 565?

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

What is the FDA product code for OLLI 565?

The FDA product code for OLLI 565 is DRT.

Other records listing Kone Instruments, 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.

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Related Devices (Code: DRT)

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

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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