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FDA 510(k)

ALTADYNE

K-Number: K953675 · 1995-09-28

ApplicantLumex, Inc.
Decision Date1995-09-28
Product CodeFNM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ALTADYNE is the device name listed in this FDA 510(k) record. The listed applicant is Lumex, Inc.. It received FDA 510(k) clearance on 1995-09-28 under 510(k) number K953675. 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 ALTADYNE?

ALTADYNE is a medical device that received FDA 510(k) clearance on 1995-09-28. The listed applicant is Lumex, Inc.. The 510(k) number is K953675.

When did ALTADYNE receive FDA 510(k) clearance?

ALTADYNE received FDA 510(k) clearance on 1995-09-28, under 510(k) number K953675.

Who is the listed applicant for ALTADYNE?

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

What is the FDA product code for ALTADYNE?

The FDA product code for ALTADYNE is FNM.

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Other records listing Lumex, 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.

K963674LUMEX AIRK962123AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEMK945175MECHANICAL WHEELCHAIR 890.3850K945257577ES (ERGOSENSE)K944574LUMEX WHEELCHAIRS (SER. 1000, 3000, 4000, 5000, TILT-IN-SPACE, 6000, MRI)K923977AKROTECH 4000

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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