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FDA 510(k)

EDENTEC MODEL 2860 PRESSURE METER

K-Number: K891540 · 1989-06-01

ApplicantEdentec Corp.
Decision Date1989-06-01
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EDENTEC MODEL 2860 PRESSURE METER is the device name listed in this FDA 510(k) record. The listed applicant is Edentec Corp.. It received FDA 510(k) clearance on 1989-06-01 under 510(k) number K891540. The device is classified under product code BYE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDENTEC MODEL 2860 PRESSURE METER?

EDENTEC MODEL 2860 PRESSURE METER is a medical device that received FDA 510(k) clearance on 1989-06-01. The listed applicant is Edentec Corp.. The 510(k) number is K891540.

When did EDENTEC MODEL 2860 PRESSURE METER receive FDA 510(k) clearance?

EDENTEC MODEL 2860 PRESSURE METER received FDA 510(k) clearance on 1989-06-01, under 510(k) number K891540.

Who is the listed applicant for EDENTEC MODEL 2860 PRESSURE METER?

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 2860 PRESSURE METER?

The FDA product code for EDENTEC MODEL 2860 PRESSURE METER is BYE.

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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 3170K910871EDENTEC DIGITAL CHARTER MODEL 3710K910870EDENTEC MODEL 3711 DIGITAL RECORDER

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Related Devices (Code: BYE)

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K160112Besmed PEEP ValveBesmed Health Business CorpK122610PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIESSen MU Technology Co., Ltd.K112546O_TWO CPAP SYSTEMO-Two Medical Technologies, Inc.K110713WATERPAP VALVEAirways Development, LLCK103833NEOPIP PATIENT CIRCUIT WITH PEEPNeoforce Group, Inc.K092029VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310Draeger Medical AG & Co. KG

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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