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FDA 510(k)

MODEL 8100 PRE-FILLED INTRAUTERINE

K-Number: K790418 · 1979-03-21

ApplicantGe Medical Systems Information Technologies
Decision Date1979-03-21
Product CodeKXO
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MODEL 8100 PRE-FILLED INTRAUTERINE is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies. It received FDA 510(k) clearance on 1979-03-21 under 510(k) number K790418. 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 MODEL 8100 PRE-FILLED INTRAUTERINE?

MODEL 8100 PRE-FILLED INTRAUTERINE is a medical device that received FDA 510(k) clearance on 1979-03-21. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K790418.

When did MODEL 8100 PRE-FILLED INTRAUTERINE receive FDA 510(k) clearance?

MODEL 8100 PRE-FILLED INTRAUTERINE received FDA 510(k) clearance on 1979-03-21, under 510(k) number K790418.

Who is the listed applicant for MODEL 8100 PRE-FILLED INTRAUTERINE?

The FDA 510(k) record lists Ge Medical Systems Information Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 8100 PRE-FILLED INTRAUTERINE?

The FDA product code for MODEL 8100 PRE-FILLED INTRAUTERINE is KXO.

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Related Devices (Code: KXO)

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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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