FDA 510(k)

KAR

K-Number: K961732 · 1997-07-08

Decision Date1997-07-08

Product CodeMEH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

KAR is the device name listed in this FDA 510(k) record. The listed applicant is Landos, Inc.. It received FDA 510(k) clearance on 1997-07-08 under 510(k) number K961732. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KAR?

KAR is a medical device that received FDA 510(k) clearance on 1997-07-08. The listed applicant is Landos, Inc.. The 510(k) number is K961732.

When did KAR receive FDA 510(k) clearance?

KAR received FDA 510(k) clearance on 1997-07-08, under 510(k) number K961732.

Who is the listed applicant for KAR?

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

What is the FDA product code for KAR?

The FDA product code for KAR is MEH.

Other records listing Landos, 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.