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FDA 510(k)

ERGOMAT 8000 SYSTEM

K-Number: K952092 · 1995-07-26

ApplicantErgo-Air, Inc.
Decision Date1995-07-26
Product CodeFNM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ERGOMAT 8000 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ergo-Air, Inc.. It received FDA 510(k) clearance on 1995-07-26 under 510(k) number K952092. The device is classified under product code FNM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERGOMAT 8000 SYSTEM?

ERGOMAT 8000 SYSTEM is a medical device that received FDA 510(k) clearance on 1995-07-26. The listed applicant is Ergo-Air, Inc.. The 510(k) number is K952092.

When did ERGOMAT 8000 SYSTEM receive FDA 510(k) clearance?

ERGOMAT 8000 SYSTEM received FDA 510(k) clearance on 1995-07-26, under 510(k) number K952092.

Who is the listed applicant for ERGOMAT 8000 SYSTEM?

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

What is the FDA product code for ERGOMAT 8000 SYSTEM?

The FDA product code for ERGOMAT 8000 SYSTEM is FNM.

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 Ergo-Air, 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.

K954162ERGOSEAT SYSTEMK952093ERGOMAT 5000 SYSTEM

Related Devices (Code: FNM)

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.

K973169PRESSURE GUARD SITE SELECT (A)Span-America Medical Systems, Inc.K972022ZAK-2000Cardio Systems, Inc.K974319MIGHTY AIRWheelchairs of KansasK974070PHYSIO/1000Physio Designs, Inc.K972549SIMPULSEKinetic Concepts, Inc.K970081SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEMCathay Consolidated, 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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