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FDA 510(k)

EEE

K-Number: K953540 · 1995-08-25

ApplicantEdentec Corp.
Decision Date1995-08-25
Product CodeBYD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EEE is the device name listed in this FDA 510(k) record. The listed applicant is Edentec Corp.. It received FDA 510(k) clearance on 1995-08-25 under 510(k) number K953540. The device is classified under product code BYD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EEE?

EEE is a medical device that received FDA 510(k) clearance on 1995-08-25. The listed applicant is Edentec Corp.. The 510(k) number is K953540.

When did EEE receive FDA 510(k) clearance?

EEE received FDA 510(k) clearance on 1995-08-25, under 510(k) number K953540.

Who is the listed applicant for EEE?

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 EEE?

The FDA product code for EEE is BYD.

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 RECORDERK921819EDENTEC MODEL 3710 I DIGITAL PRINTERK913749EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170K910871EDENTEC DIGITAL CHARTER MODEL 3710K910870EDENTEC MODEL 3711 DIGITAL RECORDERK905575MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON

View all 18 devices →

Related Devices (Code: BYD)

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.

K955008HEAT & MOISTURE EXCHANGERIntertech Resources, Inc.K954194DISPOSABLE HME/FILTEREngstrom MedicalK953580HEAT MOISTURE EXCHANGERIntertech Resources, Inc.K953507TYPE 1 & 2 (HUMIDAIR I & II)Icor ABK953544HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHTGibeck, Inc.K953620WARM N WET HMEF W/LUER ADAPTERHospitak, Inc.

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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