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FDA 510(k)

MODIFICATION TO RESQPOD CIRCULATORY ENHANCER

K-Number: K033401 · 2003-11-20

ApplicantAdvanced Circulatory Systems, Inc.
Decision Date2003-11-20
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO RESQPOD CIRCULATORY ENHANCER is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Circulatory Systems, Inc.. It received FDA 510(k) clearance on 2003-11-20 under 510(k) number K033401. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO RESQPOD CIRCULATORY ENHANCER?

MODIFICATION TO RESQPOD CIRCULATORY ENHANCER is a medical device that received FDA 510(k) clearance on 2003-11-20. The listed applicant is Advanced Circulatory Systems, Inc.. The 510(k) number is K033401.

When did MODIFICATION TO RESQPOD CIRCULATORY ENHANCER receive FDA 510(k) clearance?

MODIFICATION TO RESQPOD CIRCULATORY ENHANCER received FDA 510(k) clearance on 2003-11-20, under 510(k) number K033401.

Who is the listed applicant for MODIFICATION TO RESQPOD CIRCULATORY ENHANCER?

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

What is the FDA product code for MODIFICATION TO RESQPOD CIRCULATORY ENHANCER?

The FDA product code for MODIFICATION TO RESQPOD CIRCULATORY ENHANCER is BWF.

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.

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Other records listing Advanced Circulatory Systems, 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.

K070490CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR)K040084LIFESTYLE CIRCULATORY ENHANCER

Related Devices (Code: BWF)

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.

K241152InSeeTidal Medical Technologies, LLCK233855AllPEPEnchant Tek Co. , Ltd.K221058LungTrainer (MD2 & MD3)Lung Trainers, LLCK222018Breathe+Peep Medical, LLC Dba Go2 DevicesK220565Hudson RCI Triflo II Incentive Deep Breathing ExerciserMedline Industries, Inc.K203378PulsehalerRespinova, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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