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FDA 510(k)

SLEEPSTRIP DISPOSABLE APNEA SCREENER

K-Number: K002135 · 2000-12-06

ApplicantInfluent , Ltd.
Decision Date2000-12-06
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SLEEPSTRIP DISPOSABLE APNEA SCREENER is the device name listed in this FDA 510(k) record. The listed applicant is Influent , Ltd.. It received FDA 510(k) clearance on 2000-12-06 under 510(k) number K002135. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLEEPSTRIP DISPOSABLE APNEA SCREENER?

SLEEPSTRIP DISPOSABLE APNEA SCREENER is a medical device that received FDA 510(k) clearance on 2000-12-06. The listed applicant is Influent , Ltd.. The 510(k) number is K002135.

When did SLEEPSTRIP DISPOSABLE APNEA SCREENER receive FDA 510(k) clearance?

SLEEPSTRIP DISPOSABLE APNEA SCREENER received FDA 510(k) clearance on 2000-12-06, under 510(k) number K002135.

Who is the listed applicant for SLEEPSTRIP DISPOSABLE APNEA SCREENER?

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

What is the FDA product code for SLEEPSTRIP DISPOSABLE APNEA SCREENER?

The FDA product code for SLEEPSTRIP DISPOSABLE APNEA SCREENER is MNR.

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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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