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FDA 510(k)

FETALGARD 3000 FETAL MONITOR

K-Number: K983395 · 1999-08-12

ApplicantAnalogic Corp.
Decision Date1999-08-12
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FETALGARD 3000 FETAL MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Analogic Corp.. It received FDA 510(k) clearance on 1999-08-12 under 510(k) number K983395. 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 FETAL MONITOR?

FETALGARD 3000 FETAL MONITOR is a medical device that received FDA 510(k) clearance on 1999-08-12. The listed applicant is Analogic Corp.. The 510(k) number is K983395.

When did FETALGARD 3000 FETAL MONITOR receive FDA 510(k) clearance?

FETALGARD 3000 FETAL MONITOR received FDA 510(k) clearance on 1999-08-12, under 510(k) number K983395.

Who is the listed applicant for FETALGARD 3000 FETAL MONITOR?

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 FETAL MONITOR?

The FDA product code for FETALGARD 3000 FETAL MONITOR 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

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.

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