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FDA 510(k)

BIOMEDIX PADNET LAB

K-Number: K042616 · 2004-10-12

ApplicantBiomedix, Inc.
Decision Date2004-10-12
Product CodeJOM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOMEDIX PADNET LAB is the device name listed in this FDA 510(k) record. The listed applicant is Biomedix, Inc.. It received FDA 510(k) clearance on 2004-10-12 under 510(k) number K042616. The device is classified under product code JOM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMEDIX PADNET LAB?

BIOMEDIX PADNET LAB is a medical device that received FDA 510(k) clearance on 2004-10-12. The listed applicant is Biomedix, Inc.. The 510(k) number is K042616.

When did BIOMEDIX PADNET LAB receive FDA 510(k) clearance?

BIOMEDIX PADNET LAB received FDA 510(k) clearance on 2004-10-12, under 510(k) number K042616.

Who is the listed applicant for BIOMEDIX PADNET LAB?

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

What is the FDA product code for BIOMEDIX PADNET LAB?

The FDA product code for BIOMEDIX PADNET LAB is JOM.

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Other records listing Biomedix, 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.

K122281PADNET 2.0K073146PADNET+K050182Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEMK033627Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEMK973857FLOSTAT VASCULAR REPORT GENERATOR (VRG)K973644FLOSTAT VASCULAR LAB

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Related Devices (Code: JOM)

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.

K220527PADnet XpressCollaborative Care Diagnostics, LLC, D.B.A. BiomedixK213730MESI mTABLET TBI diagnostic system, MESI mTABLET TBIMesi, Development of Medical Devices, Ltd.; Mesi D.O.O.K200567ASI Plethysmogrpah AnalyzerArterial Stiffness, Inc.K201046Automated ankle brachial pressure index measuring device, MESI mTABLET systemMesi D.O.O.; Mesi, Development of Medical Devices, Ltd.K191266VitalScan ANSMedeia, Inc.K172655Automated ankle brachial pressure index measuring deviceMesi D.O.O.; Mesi, Development of Medical Devices, Ltd.

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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