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FDA 510(k)

PADNET+

K-Number: K073146 · 2007-11-21

ApplicantBiomedix, Inc.
Decision Date2007-11-21
Product CodeJOM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PADNET+ is the device name listed in this FDA 510(k) record. The listed applicant is Biomedix, Inc.. It received FDA 510(k) clearance on 2007-11-21 under 510(k) number K073146. 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 PADNET+?

PADNET+ is a medical device that received FDA 510(k) clearance on 2007-11-21. The listed applicant is Biomedix, Inc.. The 510(k) number is K073146.

When did PADNET+ receive FDA 510(k) clearance?

PADNET+ received FDA 510(k) clearance on 2007-11-21, under 510(k) number K073146.

Who is the listed applicant for PADNET+?

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 PADNET+?

The FDA product code for PADNET+ 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 2.0K050182Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEMK042616BIOMEDIX PADNET LABK033627Q.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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