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FDA 510(k)

CIRCAPAK

K-Number: K792268 · 1979-11-27

ApplicantRespiratory Care, Inc.
Decision Date1979-11-27
Product CodeBZO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CIRCAPAK 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 1979-11-27 under 510(k) number K792268. The device is classified under product code BZO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIRCAPAK?

CIRCAPAK is a medical device that received FDA 510(k) clearance on 1979-11-27. The listed applicant is Respiratory Care, Inc.. The 510(k) number is K792268.

When did CIRCAPAK receive FDA 510(k) clearance?

CIRCAPAK received FDA 510(k) clearance on 1979-11-27, under 510(k) number K792268.

Who is the listed applicant for CIRCAPAK?

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?

The FDA product code for CIRCAPAK is BZO.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 26 devices →

Related Devices (Code: BZO)

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.

K953784UNICOR, INC. CORRUGATED TUBINGUnicor, Inc.K953785UNICOR, INC. VENTILATOR HOSESUnicor, Inc.K952011PRIMA BREATHING BAGSPrima, Inc.K952010PRIMA VENTILATOR HOSESPrima, Inc.K952022PRIMA VOLUMN VENTILATORSSPrima, Inc.K952012PRIMA CUSTOM ANESTESIA CIRCUITPrima, 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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