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FDA 510(k)

AREMA II

K-Number: K961129 · 1996-04-17

ApplicantMellen Air Mfg., Inc.
Decision Date1996-04-17
Product CodeFNM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AREMA II is the device name listed in this FDA 510(k) record. The listed applicant is Mellen Air Mfg., Inc.. It received FDA 510(k) clearance on 1996-04-17 under 510(k) number K961129. 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 AREMA II?

AREMA II is a medical device that received FDA 510(k) clearance on 1996-04-17. The listed applicant is Mellen Air Mfg., Inc.. The 510(k) number is K961129.

When did AREMA II receive FDA 510(k) clearance?

AREMA II received FDA 510(k) clearance on 1996-04-17, under 510(k) number K961129.

Who is the listed applicant for AREMA II?

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

What is the FDA product code for AREMA II?

The FDA product code for AREMA II 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 Mellen Air Mfg., 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.

K963510APREMA I - ALTERNATING PRESSURE AIR FLOTATION MATTRESS 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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