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FDA 510(k)

KAI SPOT MODEL KMS 200

K-Number: K100773 · 2010-06-23

ApplicantKai Medical, Inc.
Decision Date2010-06-23
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

KAI SPOT MODEL KMS 200 is the device name listed in this FDA 510(k) record. The listed applicant is Kai Medical, Inc.. It received FDA 510(k) clearance on 2010-06-23 under 510(k) number K100773. 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 KAI SPOT MODEL KMS 200?

KAI SPOT MODEL KMS 200 is a medical device that received FDA 510(k) clearance on 2010-06-23. The listed applicant is Kai Medical, Inc.. The 510(k) number is K100773.

When did KAI SPOT MODEL KMS 200 receive FDA 510(k) clearance?

KAI SPOT MODEL KMS 200 received FDA 510(k) clearance on 2010-06-23, under 510(k) number K100773.

Who is the listed applicant for KAI SPOT MODEL KMS 200?

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

What is the FDA product code for KAI SPOT MODEL KMS 200?

The FDA product code for KAI SPOT MODEL KMS 200 is BZQ.

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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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