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FDA 510(k)

NOVA OXYGEN TENT

K-Number: K893713 · 1989-08-21

ApplicantNova Health Systems, Inc.
Decision Date1989-08-21
Product CodeBYL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NOVA OXYGEN TENT is the device name listed in this FDA 510(k) record. The listed applicant is Nova Health Systems, Inc.. It received FDA 510(k) clearance on 1989-08-21 under 510(k) number K893713. 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 NOVA OXYGEN TENT?

NOVA OXYGEN TENT is a medical device that received FDA 510(k) clearance on 1989-08-21. The listed applicant is Nova Health Systems, Inc.. The 510(k) number is K893713.

When did NOVA OXYGEN TENT receive FDA 510(k) clearance?

NOVA OXYGEN TENT received FDA 510(k) clearance on 1989-08-21, under 510(k) number K893713.

Who is the listed applicant for NOVA OXYGEN TENT?

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

What is the FDA product code for NOVA OXYGEN TENT?

The FDA product code for NOVA OXYGEN TENT 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 Nova Health 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.

K895477NOVA PILLOWK780502NOVA AIR FLOATATION SYSTEM

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.

K935126NASCOR IGLOONascor Pty. , Ltd.K905627NASCOR OXYDOMENascor Pty. , Ltd.K896608SPAG PAKViratek, Inc.K895866DIRD INGANT O2 (BIO 2 HOOD)Bird Products Corp.K893714KEYSTONE OXYGEN TENTKeystone Veterinary Supplies, 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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