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FDA 510(k)

EDENTEC MODEL 2000W SYSTEM 700 MONITOR

K-Number: K901060 · 1990-05-15

ApplicantEdentec Corp.
Decision Date1990-05-15
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EDENTEC MODEL 2000W SYSTEM 700 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 1990-05-15 under 510(k) number K901060. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDENTEC MODEL 2000W SYSTEM 700 MONITOR?

EDENTEC MODEL 2000W SYSTEM 700 MONITOR is a medical device that received FDA 510(k) clearance on 1990-05-15. The listed applicant is Edentec Corp.. The 510(k) number is K901060.

When did EDENTEC MODEL 2000W SYSTEM 700 MONITOR receive FDA 510(k) clearance?

EDENTEC MODEL 2000W SYSTEM 700 MONITOR received FDA 510(k) clearance on 1990-05-15, under 510(k) number K901060.

Who is the listed applicant for EDENTEC MODEL 2000W SYSTEM 700 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 SYSTEM 700 MONITOR?

The FDA product code for EDENTEC MODEL 2000W SYSTEM 700 MONITOR is DQA.

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Other records listing Edentec Corp. as applicant

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K953363OXIFLOW DIGITAL RECORDERK953540EEEK921819EDENTEC MODEL 3710 I DIGITAL PRINTERK913749EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170K910870EDENTEC MODEL 3711 DIGITAL RECORDERK910871EDENTEC DIGITAL CHARTER MODEL 3710

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Related Devices (Code: DQA)

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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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