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FDA 510(k)

MX4040 INTRAUTERINE PRESSURE MONITORING KIT

K-Number: K860101 · 1986-04-14

ApplicantMedex, Inc.
Decision Date1986-04-14
Product CodeKXO
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MX4040 INTRAUTERINE PRESSURE MONITORING KIT is the device name listed in this FDA 510(k) record. The listed applicant is Medex, Inc.. It received FDA 510(k) clearance on 1986-04-14 under 510(k) number K860101. 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 MX4040 INTRAUTERINE PRESSURE MONITORING KIT?

MX4040 INTRAUTERINE PRESSURE MONITORING KIT is a medical device that received FDA 510(k) clearance on 1986-04-14. The listed applicant is Medex, Inc.. The 510(k) number is K860101.

When did MX4040 INTRAUTERINE PRESSURE MONITORING KIT receive FDA 510(k) clearance?

MX4040 INTRAUTERINE PRESSURE MONITORING KIT received FDA 510(k) clearance on 1986-04-14, under 510(k) number K860101.

Who is the listed applicant for MX4040 INTRAUTERINE PRESSURE MONITORING KIT?

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 MX4040 INTRAUTERINE PRESSURE MONITORING KIT?

The FDA product code for MX4040 INTRAUTERINE PRESSURE MONITORING KIT is KXO.

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Other records listing Medex, Inc. as applicant

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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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