FDA 510(k)

SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC)

K-Number: K991235 · 1999-07-08

Decision Date1999-07-08

Product CodeKXO

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC) is the device name listed in this FDA 510(k) record. The listed applicant is Ludlow Technical Products. It received FDA 510(k) clearance on 1999-07-08 under 510(k) number K991235. 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 SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC)?

SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC) is a medical device that received FDA 510(k) clearance on 1999-07-08. The listed applicant is Ludlow Technical Products. The 510(k) number is K991235.

When did SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC) receive FDA 510(k) clearance?

SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC) received FDA 510(k) clearance on 1999-07-08, under 510(k) number K991235.

Who is the listed applicant for SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC)?

The FDA 510(k) record lists Ludlow Technical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC)?

The FDA product code for SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC) is KXO.

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Other records listing Ludlow Technical Products as applicant

K973110LUDLOW TECHNICAL PRODUCTS, ELECTRODE, ELECTROSURGICAL, DISPOSABLE PEDIATRIC DISPERSIVE ELECTRODES; WITH AND WITHOUT CORD K972646AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES K964401KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4)K931903SURELOCK(TM) SNAPLESS MONITORING ELECTRODE

Related Devices (Code: KXO)

K982565EASY TRANS TIPCarl Schuh K974730SOFTRANS 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, LLC K950498LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETERGraphic Controls Corp.K950708LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000Graphic Controls Corp.

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.