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FDA 510(k)

KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100

K-Number: K090273 · 2009-06-05

ApplicantKai Sensors, Inc.
Decision Date2009-06-05
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100 is the device name listed in this FDA 510(k) record. The listed applicant is Kai Sensors, Inc.. It received FDA 510(k) clearance on 2009-06-05 under 510(k) number K090273. 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 SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100?

KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100 is a medical device that received FDA 510(k) clearance on 2009-06-05. The listed applicant is Kai Sensors, Inc.. The 510(k) number is K090273.

When did KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100 receive FDA 510(k) clearance?

KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100 received FDA 510(k) clearance on 2009-06-05, under 510(k) number K090273.

Who is the listed applicant for KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100?

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

What is the FDA product code for KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100?

The FDA product code for KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100 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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