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FDA 510(k)

FETALGARD LITE

K-Number: K002503 · 2000-11-09

ApplicantAnalogic Corp.
Decision Date2000-11-09
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FETALGARD LITE is the device name listed in this FDA 510(k) record. The listed applicant is Analogic Corp.. It received FDA 510(k) clearance on 2000-11-09 under 510(k) number K002503. 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 LITE?

FETALGARD LITE is a medical device that received FDA 510(k) clearance on 2000-11-09. The listed applicant is Analogic Corp.. The 510(k) number is K002503.

When did FETALGARD LITE receive FDA 510(k) clearance?

FETALGARD LITE received FDA 510(k) clearance on 2000-11-09, under 510(k) number K002503.

Who is the listed applicant for FETALGARD LITE?

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 LITE?

The FDA product code for FETALGARD LITE is HGM.

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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

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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.

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