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)

FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3

K-Number: K950420 · 1995-05-15

ApplicantAnalogic Corp.
Decision Date1995-05-15
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3 is the device name listed in this FDA 510(k) record. The listed applicant is Analogic Corp.. It received FDA 510(k) clearance on 1995-05-15 under 510(k) number K950420. 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 FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3?

FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3 is a medical device that received FDA 510(k) clearance on 1995-05-15. The listed applicant is Analogic Corp.. The 510(k) number is K950420.

When did FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3 receive FDA 510(k) clearance?

FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3 received FDA 510(k) clearance on 1995-05-15, under 510(k) number K950420.

Who is the listed applicant for FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3?

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

What is the FDA product code for FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3?

The FDA product code for FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3 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 Analogic Corp. 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.

K071430SYNERAD OMNI, MODELS AN6255 AND AN6265K052447SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600K050919LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423PK043025SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250K041434C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORSK041376C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925A

View all 32 devices →

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.

↑