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FDA 510(k)

MEDICALEX

K-Number: K831728 · 1984-01-09

ApplicantMedicalex
Decision Date1984-01-09
Product CodeFQM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDICALEX is the device name listed in this FDA 510(k) record. The listed applicant is Medicalex. It received FDA 510(k) clearance on 1984-01-09 under 510(k) number K831728. The device is classified under product code FQM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDICALEX?

MEDICALEX is a medical device that received FDA 510(k) clearance on 1984-01-09. The listed applicant is Medicalex. The 510(k) number is K831728.

When did MEDICALEX receive FDA 510(k) clearance?

MEDICALEX received FDA 510(k) clearance on 1984-01-09, under 510(k) number K831728.

Who is the listed applicant for MEDICALEX?

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

What is the FDA product code for MEDICALEX?

The FDA product code for MEDICALEX is FQM.

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Other records listing Medicalex 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.

K850946SURGICAL ASPIRATORK851349LERE NAIL & PLATE COMBIN. ONE PIECE FORGEDK833377MEDICALEX

Related Devices (Code: FQM)

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.

K040936PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDELeda Co., Ltd.K040054BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLETheodore BarashK013244COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBEMed Gen, Inc.K952738SKIN SAVER SYSTEMSSkin Saver Systems, Inc.K872868ASPEN ESMARK BANDAGEAspen Laboratories, Inc.K840107TUBE-BANDAGE FOR HUMAN DIGITS 200Zens Health Care Products

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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