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FDA 510(k)

EDENTEC MODEL 3710 I DIGITAL PRINTER

K-Number: K921819 · 1993-10-22

ApplicantEdentec Corp.
Decision Date1993-10-22
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EDENTEC MODEL 3710 I DIGITAL PRINTER is the device name listed in this FDA 510(k) record. The listed applicant is Edentec Corp.. It received FDA 510(k) clearance on 1993-10-22 under 510(k) number K921819. 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 3710 I DIGITAL PRINTER?

EDENTEC MODEL 3710 I DIGITAL PRINTER is a medical device that received FDA 510(k) clearance on 1993-10-22. The listed applicant is Edentec Corp.. The 510(k) number is K921819.

When did EDENTEC MODEL 3710 I DIGITAL PRINTER receive FDA 510(k) clearance?

EDENTEC MODEL 3710 I DIGITAL PRINTER received FDA 510(k) clearance on 1993-10-22, under 510(k) number K921819.

Who is the listed applicant for EDENTEC MODEL 3710 I DIGITAL PRINTER?

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 3710 I DIGITAL PRINTER?

The FDA product code for EDENTEC MODEL 3710 I DIGITAL PRINTER 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 RECORDERK953540EEEK913749EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170K910871EDENTEC DIGITAL CHARTER MODEL 3710K910870EDENTEC MODEL 3711 DIGITAL RECORDERK905575MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON

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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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