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FDA 510(k)

KETRONIC MEDAX - N

K-Number: K843288 · 1984-11-08

ApplicantKetronic, Inc.
Decision Date1984-11-08
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KETRONIC MEDAX - N is the device name listed in this FDA 510(k) record. The listed applicant is Ketronic, Inc.. It received FDA 510(k) clearance on 1984-11-08 under 510(k) number K843288. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KETRONIC MEDAX - N?

KETRONIC MEDAX - N is a medical device that received FDA 510(k) clearance on 1984-11-08. The listed applicant is Ketronic, Inc.. The 510(k) number is K843288.

When did KETRONIC MEDAX - N receive FDA 510(k) clearance?

KETRONIC MEDAX - N received FDA 510(k) clearance on 1984-11-08, under 510(k) number K843288.

Who is the listed applicant for KETRONIC MEDAX - N?

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

What is the FDA product code for KETRONIC MEDAX - N?

The FDA product code for KETRONIC MEDAX - N is IYX.

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Other records listing Ketronic, 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.

K850869MFE COUCH ERGOMETERK850873HILO TABLES, TYPE CH-4, CH-8, FW-6, FW-5, FW-2, ALK850877MONOLIFT MPE2, PLATFORM, CHAIR, FULLY FUTO PLATFORK850870MEDIFETTE ERGOMETERK850868MFE CARDIAC STRESS SYSTEMK850872PHYACTION 300, 360, 370, 390 & 391 ELEC-MUSCLE-STI

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Related Devices (Code: IYX)

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.

K230221QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)Versant Medical Physics and Radiation SafetyK2125873D-RD-SRadiopharmaceutical Imaging and Dosimetry, LLCK163687OLINDA EXMHermes Medical Solutions ABK160933Discovery NM 750b BopsyGE HealthcareK162052Sentinella 102, Sentinella 102 HorusGeneral Equipment For Medical Imaging (Oncovision-K123408ERGO IMAGING SYSTEMDigirad Corp.

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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