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)

GENESIS TM FETAL SYSTEM

K-Number: K882084 · 1989-05-26

ApplicantPediatric Diagnostic Service
Decision Date1989-05-26
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GENESIS TM FETAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pediatric Diagnostic Service. It received FDA 510(k) clearance on 1989-05-26 under 510(k) number K882084. 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 GENESIS TM FETAL SYSTEM?

GENESIS TM FETAL SYSTEM is a medical device that received FDA 510(k) clearance on 1989-05-26. The listed applicant is Pediatric Diagnostic Service. The 510(k) number is K882084.

When did GENESIS TM FETAL SYSTEM receive FDA 510(k) clearance?

GENESIS TM FETAL SYSTEM received FDA 510(k) clearance on 1989-05-26, under 510(k) number K882084.

Who is the listed applicant for GENESIS TM FETAL SYSTEM?

The FDA 510(k) record lists Pediatric Diagnostic Service as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENESIS TM FETAL SYSTEM?

The FDA product code for GENESIS TM FETAL SYSTEM 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 Pediatric Diagnostic Service 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.

K873150PDS, MODEL NST 40 FETAL MONITOR, RECORDER & TRANS.

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.

↑