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FDA 510(k)

ISOFLO(TM) AMNIOCENTESIS TRAY

K-Number: K901643 · 1990-07-25

ApplicantHealthdyne Cardiovascular, Inc.
Decision Date1990-07-25
Product CodeHIO
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ISOFLO(TM) AMNIOCENTESIS TRAY 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 1990-07-25 under 510(k) number K901643. The device is classified under product code HIO. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOFLO(TM) AMNIOCENTESIS TRAY?

ISOFLO(TM) AMNIOCENTESIS TRAY is a medical device that received FDA 510(k) clearance on 1990-07-25. The listed applicant is Healthdyne Cardiovascular, Inc.. The 510(k) number is K901643.

When did ISOFLO(TM) AMNIOCENTESIS TRAY receive FDA 510(k) clearance?

ISOFLO(TM) AMNIOCENTESIS TRAY received FDA 510(k) clearance on 1990-07-25, under 510(k) number K901643.

Who is the listed applicant for ISOFLO(TM) AMNIOCENTESIS TRAY?

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(TM) AMNIOCENTESIS TRAY?

The FDA product code for ISOFLO(TM) AMNIOCENTESIS TRAY is HIO.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K901382ISOFLO(TM) HIGH PRESSURE INJECTION LINESK901084ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO.K900665DRESSING CHANGE KITK895763ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING

Related Devices (Code: HIO)

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.

K960203G.E. STERILE AMNIOCENTESIS TRAYGE Medical SystemsK955679RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAYContour Fabricators of Florida, Inc.K914419AMNIOTEST(TM)Pro-Lab, Inc.K922960VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLECameo, Inc.K921738SONO-VU US(TM), MODIFICATIONE-Z-Em, Inc.K915863MEGA AMNIOCENTESIS KITMega Medical, Inc.

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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