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FDA 510(k)

EDENTEC MODEL 3711 DIGITAL RECORDER

K-Number: K910870 · 1991-08-29

ApplicantEdentec Corp.
Decision Date1991-08-29
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EDENTEC MODEL 3711 DIGITAL RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Edentec Corp.. It received FDA 510(k) clearance on 1991-08-29 under 510(k) number K910870. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDENTEC MODEL 3711 DIGITAL RECORDER?

EDENTEC MODEL 3711 DIGITAL RECORDER is a medical device that received FDA 510(k) clearance on 1991-08-29. The listed applicant is Edentec Corp.. The 510(k) number is K910870.

When did EDENTEC MODEL 3711 DIGITAL RECORDER receive FDA 510(k) clearance?

EDENTEC MODEL 3711 DIGITAL RECORDER received FDA 510(k) clearance on 1991-08-29, under 510(k) number K910870.

Who is the listed applicant for EDENTEC MODEL 3711 DIGITAL RECORDER?

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 3711 DIGITAL RECORDER?

The FDA product code for EDENTEC MODEL 3711 DIGITAL RECORDER is DRT.

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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 3710K905575MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON

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Related Devices (Code: DRT)

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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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