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FDA 510(k)

CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT

K-Number: K861555 · 1986-06-05

ApplicantRespiratory Care, Inc.
Decision Date1986-06-05
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT 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 1986-06-05 under 510(k) number K861555. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT?

CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT is a medical device that received FDA 510(k) clearance on 1986-06-05. The listed applicant is Respiratory Care, Inc.. The 510(k) number is K861555.

When did CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT receive FDA 510(k) clearance?

CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT received FDA 510(k) clearance on 1986-06-05, under 510(k) number K861555.

Who is the listed applicant for CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT?

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 CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT?

The FDA product code for CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT is BZD.

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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 CONTROLLK864147AQUAVALVEK863955COLBY LEVEL ALARMK834151CONCHATHERM LHF HUMIDIFIER HEATER

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Related Devices (Code: BZD)

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.

K261262Altis Full Face MaskRespironics, Inc.K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.

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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