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FDA 510(k)

LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000

K-Number: K950708 · 1995-05-25

ApplicantGraphic Controls Corp.
Decision Date1995-05-25
Product CodeKXO
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000 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 1995-05-25 under 510(k) number K950708. 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 LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000?

LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000 is a medical device that received FDA 510(k) clearance on 1995-05-25. The listed applicant is Graphic Controls Corp.. The 510(k) number is K950708.

When did LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000 receive FDA 510(k) clearance?

LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000 received FDA 510(k) clearance on 1995-05-25, under 510(k) number K950708.

Who is the listed applicant for LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000?

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 LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000?

The FDA product code for LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000 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.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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