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FDA 510(k)

AQUAVALVE

K-Number: K864147 · 1986-12-05

ApplicantRespiratory Care, Inc.
Decision Date1986-12-05
Product CodeBYH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AQUAVALVE is the device name listed in this FDA 510(k) record. The listed applicant is Respiratory Care, Inc.. It received FDA 510(k) clearance on 1986-12-05 under 510(k) number K864147. The device is classified under product code BYH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AQUAVALVE?

AQUAVALVE is a medical device that received FDA 510(k) clearance on 1986-12-05. The listed applicant is Respiratory Care, Inc.. The 510(k) number is K864147.

When did AQUAVALVE receive FDA 510(k) clearance?

AQUAVALVE received FDA 510(k) clearance on 1986-12-05, under 510(k) number K864147.

Who is the listed applicant for AQUAVALVE?

The FDA 510(k) record lists Respiratory Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AQUAVALVE?

The FDA product code for AQUAVALVE is BYH.

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Other records listing Respiratory Care, Inc. 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.

K892230RCI VIRAL/BACTERIAL FILTERK884150MODIFIED CONCHATHERM III CONTROLLED HEATERK881625CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLLK863955COLBY LEVEL ALARMK861555CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUITK834151CONCHATHERM LHF HUMIDIFIER HEATER

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Related Devices (Code: BYH)

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.

K946057AQUALARM MOISTURE SENSOR MODEL P85000Pegasus Research Corp.K932722CARIE MED-TECH MODEL 210 RAINOUT DRAINAGE SYSTEMCarie Med-Tech Services, Inc.K921624DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITSIntertech Resources, Inc.K900047THAYER SUCTION EVACUATION CONDENSATE COLLECTIONThayer Medical Corp.K897057THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEMThayer Medical Corp.K900591VENT-TRAP CAT# WR1000Ventlab Corp.

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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