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FDA 510(k)

DRX5000

K-Number: K023160 · 2002-12-20

ApplicantAxiom Usa., Inc.
Decision Date2002-12-20
Product CodeITH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DRX5000 is the device name listed in this FDA 510(k) record. The listed applicant is Axiom Usa., Inc.. It received FDA 510(k) clearance on 2002-12-20 under 510(k) number K023160. The device is classified under product code ITH. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRX5000?

DRX5000 is a medical device that received FDA 510(k) clearance on 2002-12-20. The listed applicant is Axiom Usa., Inc.. The 510(k) number is K023160.

When did DRX5000 receive FDA 510(k) clearance?

DRX5000 received FDA 510(k) clearance on 2002-12-20, under 510(k) number K023160.

Who is the listed applicant for DRX5000?

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

What is the FDA product code for DRX5000?

The FDA product code for DRX5000 is ITH.

Other records listing Axiom Usa., 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.

K033015AXIOM BIOLASER LLLT SERIES-3K030622AXIOM BIOLASER LLLT SERIES-1K022602DRX3000

Related Devices (Code: ITH)

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.

K243775True Non-Surgical Spinal Decompression System (DRX9000-SL)Excite Medical of Tampa Bay, LLCK243366DRX9000C-SL Cervical Spinal Decompression SystemExcite Medical of Tampa Bay, LLCK214037Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-TracErgo-Flex Technologies, LLCK222912c1TracZimmer Medizinsysteme GmbHK112074EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800Everyway Medical Instruments Co.,LtdK103248INTEGRITY SPINAL CARE SYSTEMIntegra Life Sciences

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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