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FDA 510(k)

SAFECIRCUIT MANIFOLD/PULMONARY UNIT

K-Number: K953269 · 1996-12-20

ApplicantAdvanced Warming Systems, Inc.
Decision Date1996-12-20
Product CodeCBN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SAFECIRCUIT MANIFOLD/PULMONARY UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Warming Systems, Inc.. It received FDA 510(k) clearance on 1996-12-20 under 510(k) number K953269. The device is classified under product code CBN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFECIRCUIT MANIFOLD/PULMONARY UNIT?

SAFECIRCUIT MANIFOLD/PULMONARY UNIT is a medical device that received FDA 510(k) clearance on 1996-12-20. The listed applicant is Advanced Warming Systems, Inc.. The 510(k) number is K953269.

When did SAFECIRCUIT MANIFOLD/PULMONARY UNIT receive FDA 510(k) clearance?

SAFECIRCUIT MANIFOLD/PULMONARY UNIT received FDA 510(k) clearance on 1996-12-20, under 510(k) number K953269.

Who is the listed applicant for SAFECIRCUIT MANIFOLD/PULMONARY UNIT?

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

What is the FDA product code for SAFECIRCUIT MANIFOLD/PULMONARY UNIT?

The FDA product code for SAFECIRCUIT MANIFOLD/PULMONARY UNIT is CBN.

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 Advanced Warming 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.

K950771DISPOSABLE ADHESIVE FACE MASKK913016WARMTOUCH

Related Devices (Code: CBN)

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.

K223452Nitronox Scavenger PlusParker Hannifin CorporationK193646Dynamic Gas Scavenging System 2 (DGSS - 2)Anesthetic Gas Reclamation, Inc.K160950MINISCAVSedation Systems, LLCK123176ISO-GARD CLEARAIR MASKTeleflexmedical, Inc.K110930ACTIVE WASTE GAS SCAVENGERG. Dundas Co.,Inc.K092031VAPOR-CLEAR, MODEL 100Axon Medical, Inc.

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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