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FDA 510(k)

EDENTEC MODEL 2000W APNEA MONITOR

K-Number: K844327 · 1985-07-15

ApplicantEdentec Corp.
Decision Date1985-07-15
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EDENTEC MODEL 2000W APNEA MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Edentec Corp.. It received FDA 510(k) clearance on 1985-07-15 under 510(k) number K844327. 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 EDENTEC MODEL 2000W APNEA MONITOR?

EDENTEC MODEL 2000W APNEA MONITOR is a medical device that received FDA 510(k) clearance on 1985-07-15. The listed applicant is Edentec Corp.. The 510(k) number is K844327.

When did EDENTEC MODEL 2000W APNEA MONITOR receive FDA 510(k) clearance?

EDENTEC MODEL 2000W APNEA MONITOR received FDA 510(k) clearance on 1985-07-15, under 510(k) number K844327.

Who is the listed applicant for EDENTEC MODEL 2000W APNEA MONITOR?

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

What is the FDA product code for EDENTEC MODEL 2000W APNEA MONITOR?

The FDA product code for EDENTEC MODEL 2000W APNEA MONITOR is BZQ.

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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.

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