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FDA 510(k)

MDI 2000 - PULSE GENERATOR

K-Number: K850791 · 1985-06-19

ApplicantMicromedical Devices, Inc.
Decision Date1985-06-19
Product CodeDRO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MDI 2000 - PULSE GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Micromedical Devices, Inc.. It received FDA 510(k) clearance on 1985-06-19 under 510(k) number K850791. 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 MDI 2000 - PULSE GENERATOR?

MDI 2000 - PULSE GENERATOR is a medical device that received FDA 510(k) clearance on 1985-06-19. The listed applicant is Micromedical Devices, Inc.. The 510(k) number is K850791.

When did MDI 2000 - PULSE GENERATOR receive FDA 510(k) clearance?

MDI 2000 - PULSE GENERATOR received FDA 510(k) clearance on 1985-06-19, under 510(k) number K850791.

Who is the listed applicant for MDI 2000 - PULSE GENERATOR?

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

What is the FDA product code for MDI 2000 - PULSE GENERATOR?

The FDA product code for MDI 2000 - PULSE GENERATOR is DRO.

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Other records listing Micromedical Devices, 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.

K043287PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000K936195LAPAROSCOPESK936155ADAIR INSUFFLATION AND INSTRUMENTATION CANNULAK936097VIDEO CAMERAS, ENCOSCOPIC AND SURGICALK936086STERILE VIDEO CAMERA COVER AND DRAPEK834262TRANS-PACE

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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

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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