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FDA 510(k)

BREATHING CIRCUIT, BAIN

K-Number: K780044 · 1978-02-02

ApplicantRespiratory Care, Inc.
Decision Date1978-02-02
Product CodeCAI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BREATHING CIRCUIT, BAIN 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 1978-02-02 under 510(k) number K780044. The device is classified under product code CAI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREATHING CIRCUIT, BAIN?

BREATHING CIRCUIT, BAIN is a medical device that received FDA 510(k) clearance on 1978-02-02. The listed applicant is Respiratory Care, Inc.. The 510(k) number is K780044.

When did BREATHING CIRCUIT, BAIN receive FDA 510(k) clearance?

BREATHING CIRCUIT, BAIN received FDA 510(k) clearance on 1978-02-02, under 510(k) number K780044.

Who is the listed applicant for BREATHING CIRCUIT, BAIN?

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 BREATHING CIRCUIT, BAIN?

The FDA product code for BREATHING CIRCUIT, BAIN is CAI.

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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 ALARMK861555CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT

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Related Devices (Code: CAI)

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.

K954480CONDENSATE COLLECTION KITNova-VentrxK953787UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUITUnicor, Inc.K953788UNICOR, INC. GAS SAMPLING LINES & CONNECTORSUnicor, Inc.K952016PRIMA PEDIATRIC GAS SAMPLING CIRCUITSPrima, Inc.K952018PRIMA COAXIAL CIRCUITSPrima, Inc.K952020PRIMA PEDIATRIC ANESTHESIA CIRCUITSPrima, 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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