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FDA 510(k)

NASCOR IGLOO

K-Number: K935126 · 1994-10-18

ApplicantNascor Pty. , Ltd.
Decision Date1994-10-18
Product CodeBYL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NASCOR IGLOO is the device name listed in this FDA 510(k) record. The listed applicant is Nascor Pty. , Ltd.. It received FDA 510(k) clearance on 1994-10-18 under 510(k) number K935126. The device is classified under product code BYL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NASCOR IGLOO?

NASCOR IGLOO is a medical device that received FDA 510(k) clearance on 1994-10-18. The listed applicant is Nascor Pty. , Ltd.. The 510(k) number is K935126.

When did NASCOR IGLOO receive FDA 510(k) clearance?

NASCOR IGLOO received FDA 510(k) clearance on 1994-10-18, under 510(k) number K935126.

Who is the listed applicant for NASCOR IGLOO?

The FDA 510(k) record lists Nascor Pty. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NASCOR IGLOO?

The FDA product code for NASCOR IGLOO is BYL.

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 Nascor Pty. , Ltd. 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.

K905627NASCOR OXYDOME

Related Devices (Code: BYL)

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.

K905627NASCOR OXYDOMENascor Pty. , Ltd.K896608SPAG PAKViratek, Inc.K895866DIRD INGANT O2 (BIO 2 HOOD)Bird Products Corp.K893714KEYSTONE OXYGEN TENTKeystone Veterinary Supplies, Inc.K893713NOVA OXYGEN TENTNova Health Systems, Inc.K882396AEROSOL DELIVERY HOODViratek, 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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