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FDA 510(k)

ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO.

K-Number: K901084 · 1990-06-01

ApplicantHealthdyne Cardiovascular, Inc.
Decision Date1990-06-01
Product CodeKXO
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO. is the device name listed in this FDA 510(k) record. The listed applicant is Healthdyne Cardiovascular, Inc.. It received FDA 510(k) clearance on 1990-06-01 under 510(k) number K901084. 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 ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO.?

ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO. is a medical device that received FDA 510(k) clearance on 1990-06-01. The listed applicant is Healthdyne Cardiovascular, Inc.. The 510(k) number is K901084.

When did ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO. receive FDA 510(k) clearance?

ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO. received FDA 510(k) clearance on 1990-06-01, under 510(k) number K901084.

Who is the listed applicant for ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO.?

The FDA 510(k) record lists Healthdyne Cardiovascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO.?

The FDA product code for ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO. is KXO.

Related Clinical Trials

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.

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Other records listing Healthdyne Cardiovascular, Inc. 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.

K901643ISOFLO(TM) AMNIOCENTESIS TRAYK901382ISOFLO(TM) HIGH PRESSURE INJECTION LINESK900665DRESSING CHANGE KITK895763ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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