Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM

K-Number: K952329 · 1996-01-17

ApplicantProgressive Dynamics, Inc.
Decision Date1996-01-17
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Progressive Dynamics, Inc.. It received FDA 510(k) clearance on 1996-01-17 under 510(k) number K952329. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM?

LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 1996-01-17. The listed applicant is Progressive Dynamics, Inc.. The 510(k) number is K952329.

When did LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM receive FDA 510(k) clearance?

LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM received FDA 510(k) clearance on 1996-01-17, under 510(k) number K952329.

Who is the listed applicant for LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM?

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

What is the FDA product code for LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM?

The FDA product code for LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM is DWJ.

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 Progressive Dynamics, 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.

K944688LUMINOUS 150 DUAL LAMPFIBEROPTIC ILLUMINATORK933764LIFE-AIR 1000 PATIENT WARMING COVERK933593LUMINOUS 150 FIBEROPTIC ILLUMINATORK921866LUMINOUS 250 FIBEROPTIC ILLUMINATORK914382LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEMK914383LIFE-AIR 1000 PATIENT WARMING COVERS

View all 7 devices →

Related Devices (Code: DWJ)

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.

K262089Disposable Warming BlanketHangzhou Tappa Medical Technology Co., Ltd.K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC LifeK260278ThermAffyx(TM) Patient Safety SystemStihler Electronic GmbHK260903Hot Pink Pad Warming SystemXodus Medical, Inc.K252861Warming SystemHangzhou Tappa Medical Technology Co., Ltd.K251974Arctic Sun Temperature Management System (Model 5000)Medivance, 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.

↑