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FDA 510(k)

MX4042/MC4044 SERIES SIMULCATH(TM)

K-Number: K922323 · 1994-06-14

ApplicantMedex, Inc.
Decision Date1994-06-14
Product CodeKXO
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MX4042/MC4044 SERIES SIMULCATH(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Medex, Inc.. It received FDA 510(k) clearance on 1994-06-14 under 510(k) number K922323. The device is classified under product code KXO. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MX4042/MC4044 SERIES SIMULCATH(TM)?

MX4042/MC4044 SERIES SIMULCATH(TM) is a medical device that received FDA 510(k) clearance on 1994-06-14. The listed applicant is Medex, Inc.. The 510(k) number is K922323.

When did MX4042/MC4044 SERIES SIMULCATH(TM) receive FDA 510(k) clearance?

MX4042/MC4044 SERIES SIMULCATH(TM) received FDA 510(k) clearance on 1994-06-14, under 510(k) number K922323.

Who is the listed applicant for MX4042/MC4044 SERIES SIMULCATH(TM)?

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

What is the FDA product code for MX4042/MC4044 SERIES SIMULCATH(TM)?

The FDA product code for MX4042/MC4044 SERIES SIMULCATH(TM) is KXO.

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Other records listing Medex, 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.

K042432PHARMGUARD TOOLBOX, MODEL G6000782K040899MEDEX 3000 SERIES MR SYRINGE INFUSION PUMPK020780TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICPK000328MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMPK982640MEDEX 3000 SERIES SYRINGE INFUSION PUMPK982123CONTRAST CONTROL DEVICE

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Related Devices (Code: KXO)

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.

K991235SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC)Ludlow Technical ProductsK982565EASY TRANS TIPCarl SchuhK974730SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)Graphic Controls Corp.K964279SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)Graphic Controls Corp.K961290IUP - TIP TRANS, IUP - PROXI TRANSScientific Device Manufacturer, LLCK950498LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETERGraphic Controls Corp.

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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