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FDA 510(k)

SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)

K-Number: K964279 · 1997-01-22

ApplicantGraphic Controls Corp.
Decision Date1997-01-22
Product CodeKXO
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) is the device name listed in this FDA 510(k) record. The listed applicant is Graphic Controls Corp.. It received FDA 510(k) clearance on 1997-01-22 under 510(k) number K964279. 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 INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)?

SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) is a medical device that received FDA 510(k) clearance on 1997-01-22. The listed applicant is Graphic Controls Corp.. The 510(k) number is K964279.

When did SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) receive FDA 510(k) clearance?

SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) received FDA 510(k) clearance on 1997-01-22, under 510(k) number K964279.

Who is the listed applicant for SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)?

The FDA 510(k) record lists Graphic Controls Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)?

The FDA product code for SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) is KXO.

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Other records listing Graphic Controls Corp. 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.

K981964MEDI-TRACE 4103 NEONATAL ELECTRODEK983287MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODEK974730SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)K980857MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODEK972970MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODEK964387POINT OF USE II SHARPS-A-GATOR

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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.K961290IUP - TIP TRANS, IUP - PROXI TRANSScientific Device Manufacturer, LLCK950498LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETERGraphic Controls Corp.K950708LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000Graphic 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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