Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FETASCAN 1500

K-Number: K860295 · 1986-05-19

ApplicantInternational Biomedics, Inc.
Decision Date1986-05-19
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FETASCAN 1500 is the device name listed in this FDA 510(k) record. The listed applicant is International Biomedics, Inc.. It received FDA 510(k) clearance on 1986-05-19 under 510(k) number K860295. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FETASCAN 1500?

FETASCAN 1500 is a medical device that received FDA 510(k) clearance on 1986-05-19. The listed applicant is International Biomedics, Inc.. The 510(k) number is K860295.

When did FETASCAN 1500 receive FDA 510(k) clearance?

FETASCAN 1500 received FDA 510(k) clearance on 1986-05-19, under 510(k) number K860295.

Who is the listed applicant for FETASCAN 1500?

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

What is the FDA product code for FETASCAN 1500?

The FDA product code for FETASCAN 1500 is HGM.

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 International Biomedics, 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.

K031096MODIFICATION TO TRANSPORT INCUBATOR 185K862072FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01K860933AIR-CUSHION TOCOTONOMETERK852439FETA SCAN 1000 OBSTETRICAL IMAGER

Related Devices (Code: HGM)

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.

K254036Novii+ Wireless Patch SystemDatex Ohmeda, Inc.K253021ANNE MaternalSibel Health, Inc.K250777Sonicaid Team3Huntleigh Healthcare , Ltd.K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.K241368Sonicaid Team3Huntleigh Healthcare , Ltd.K241009PeriCALM Patterns 3.0Perigen, 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.

↑