FDA 510(k)

560

K-Number: K822952 · 1982-11-01

Decision Date1982-11-01

Product CodeDRT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

560 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 1982-11-01 under 510(k) number K822952. 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 560?

560 is a medical device that received FDA 510(k) clearance on 1982-11-01. The listed applicant is Kone Instruments, Inc.. The 510(k) number is K822952.

When did 560 receive FDA 510(k) clearance?

560 received FDA 510(k) clearance on 1982-11-01, under 510(k) number K822952.

Who is the listed applicant for 560?

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 560?

The FDA product code for 560 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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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.