FDA 510(k)

RIVER MEDICAL MICRODRILL SYSTEM

K-Number: K905437 · 1991-05-30

Decision Date1991-05-30

Product CodeEQH

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

RIVER MEDICAL MICRODRILL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is River Medical, Inc.. It received FDA 510(k) clearance on 1991-05-30 under 510(k) number K905437. The device is classified under product code EQH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIVER MEDICAL MICRODRILL SYSTEM?

RIVER MEDICAL MICRODRILL SYSTEM is a medical device that received FDA 510(k) clearance on 1991-05-30. The listed applicant is River Medical, Inc.. The 510(k) number is K905437.

When did RIVER MEDICAL MICRODRILL SYSTEM receive FDA 510(k) clearance?

RIVER MEDICAL MICRODRILL SYSTEM received FDA 510(k) clearance on 1991-05-30, under 510(k) number K905437.

Who is the listed applicant for RIVER MEDICAL MICRODRILL SYSTEM?

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

What is the FDA product code for RIVER MEDICAL MICRODRILL SYSTEM?

The FDA product code for RIVER MEDICAL MICRODRILL SYSTEM is EQH.

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Other records listing River Medical, Inc. as applicant

K023174DISPOSABLE TEMPORARY PACING WIRE K944351SMARTDOSE IV PREFILLED INFUSION CONTAINER K944352SMARTDOSE III INFUSION CONTAINER K945298SMARTFLOW I ADMINISTRATION SET K943692SMART DOSE(TM)K932895RIVER PUMP

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Related Devices (Code: EQH)

K945876WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHTWells Johnson Co.K954184JED-LIGHT FIBEROPTIC LIGHT SOURCEJedmed Instrument Co.K951829COLD LIGHT SOURCE LOS 150Laser-Optik-Systeme GmbH & Co. KG K932771BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCEXomed-Treace, Inc.K941661GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHTGm Engineering, Inc.K941662GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHTGm Engineering, 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.