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FDA 510(k)

AVOXIMETER 4000

K-Number: K951485 · 1995-11-06

ApplicantA-Vox Systems, Inc.
Decision Date1995-11-06
Product CodeJKS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AVOXIMETER 4000 is the device name listed in this FDA 510(k) record. The listed applicant is A-Vox Systems, Inc.. It received FDA 510(k) clearance on 1995-11-06 under 510(k) number K951485. The device is classified under product code JKS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AVOXIMETER 4000?

AVOXIMETER 4000 is a medical device that received FDA 510(k) clearance on 1995-11-06. The listed applicant is A-Vox Systems, Inc.. The 510(k) number is K951485.

When did AVOXIMETER 4000 receive FDA 510(k) clearance?

AVOXIMETER 4000 received FDA 510(k) clearance on 1995-11-06, under 510(k) number K951485.

Who is the listed applicant for AVOXIMETER 4000?

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

What is the FDA product code for AVOXIMETER 4000?

The FDA product code for AVOXIMETER 4000 is JKS.

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 A-Vox 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.

K932954AVOXIMETERK922075AVOXIMETER

Related Devices (Code: JKS)

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.

K863825CO-OXIMETER SOLUTIONSD.R.G. Scientific IndustriesK862253IL 482 CO-OXIMETERInstrumentation Laboratory COK853990OSM3 HEMOXIMETERRadiometer America, Inc.K833693TEE ADAPTER 9890-FLUSH WINDING 282Shaban Mfg. Co.K833211BILE SALTS MIXTUREAcumedia Manufacturers, Inc.K832066CONTROL 282Bio-Nustics, 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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