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FDA 510(k)

CMI 3000

K-Number: K854233 · 1986-01-08

ApplicantCardio Management, Inc.
Decision Date1986-01-08
Product CodeDRO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CMI 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Management, Inc.. It received FDA 510(k) clearance on 1986-01-08 under 510(k) number K854233. The device is classified under product code DRO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CMI 3000?

CMI 3000 is a medical device that received FDA 510(k) clearance on 1986-01-08. The listed applicant is Cardio Management, Inc.. The 510(k) number is K854233.

When did CMI 3000 receive FDA 510(k) clearance?

CMI 3000 received FDA 510(k) clearance on 1986-01-08, under 510(k) number K854233.

Who is the listed applicant for CMI 3000?

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

What is the FDA product code for CMI 3000?

The FDA product code for CMI 3000 is DRO.

Related Devices (Code: DRO)

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.

K012218LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODESThe Ludlow Company LPK012404K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85Katecho, Inc.K000660ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413Medical Data ElectronicsK983196PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)Tz Medical, Inc.K983232PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERTTz Medical, Inc.K974034PORTABLE INTENSIVE CARE UNITMedical Research Laboratories, Inc.

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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