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FDA 510(k)

MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION)

K-Number: K955931 · 1996-08-14

ApplicantAdvanced Medical Systems, Inc.
Decision Date1996-08-14
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Systems, Inc.. It received FDA 510(k) clearance on 1996-08-14 under 510(k) number K955931. 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 MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION)?

MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1996-08-14. The listed applicant is Advanced Medical Systems, Inc.. The 510(k) number is K955931.

When did MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION) receive FDA 510(k) clearance?

MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION) received FDA 510(k) clearance on 1996-08-14, under 510(k) number K955931.

Who is the listed applicant for MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION)?

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

What is the FDA product code for MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION)?

The FDA product code for MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION) 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.

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Other records listing Advanced Medical Systems, 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.

K952031ULTRASOUND TRANSDUCER, MODEL US917K940898MODEL IM77 INTRAPARTUM FETAL MONITORK923335ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATIONK932278PFM PROFESSIONAL 7000 SPIROMETERK911657FETAL SCALP SPIRAL ELECTRODEK902190FETAL PULSE DETECTOR MODEL DOP-1

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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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