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FDA 510(k)

MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON

K-Number: K905575 · 1991-06-20

ApplicantEdentec Corp.
Decision Date1991-06-20
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON is the device name listed in this FDA 510(k) record. The listed applicant is Edentec Corp.. It received FDA 510(k) clearance on 1991-06-20 under 510(k) number K905575. 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 MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON?

MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON is a medical device that received FDA 510(k) clearance on 1991-06-20. The listed applicant is Edentec Corp.. The 510(k) number is K905575.

When did MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON receive FDA 510(k) clearance?

MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON received FDA 510(k) clearance on 1991-06-20, under 510(k) number K905575.

Who is the listed applicant for MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON?

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 MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON?

The FDA product code for MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON is BZQ.

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Other records listing Edentec Corp. 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.

K953363OXIFLOW DIGITAL RECORDERK953540EEEK921819EDENTEC MODEL 3710 I DIGITAL PRINTERK913749EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170K910871EDENTEC DIGITAL CHARTER MODEL 3710K910870EDENTEC MODEL 3711 DIGITAL RECORDER

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Related Devices (Code: 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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