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FDA 510(k)

DIGITMATIC DM2

K-Number: K851128 · 1985-07-19

ApplicantMedimatic
Decision Date1985-07-19
Product CodeJOM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DIGITMATIC DM2 is the device name listed in this FDA 510(k) record. The listed applicant is Medimatic. It received FDA 510(k) clearance on 1985-07-19 under 510(k) number K851128. 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 DIGITMATIC DM2?

DIGITMATIC DM2 is a medical device that received FDA 510(k) clearance on 1985-07-19. The listed applicant is Medimatic. The 510(k) number is K851128.

When did DIGITMATIC DM2 receive FDA 510(k) clearance?

DIGITMATIC DM2 received FDA 510(k) clearance on 1985-07-19, under 510(k) number K851128.

Who is the listed applicant for DIGITMATIC DM2?

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

What is the FDA product code for DIGITMATIC DM2?

The FDA product code for DIGITMATIC DM2 is JOM.

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Other records listing Medimatic 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.

K862511TOMOMATIC 232K810006TOMOMATIC 64K781742INHAMATIC 33K781352STRAIN GAUGE PLETHYSMOGRAPH

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

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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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