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FDA 510(k)

FETAL SCALP SPIRAL ELECTRODE

K-Number: K911657 · 1991-07-11

ApplicantAdvanced Medical Systems, Inc.
Decision Date1991-07-11
Product CodeHGP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FETAL SCALP SPIRAL ELECTRODE 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 1991-07-11 under 510(k) number K911657. The device is classified under product code HGP. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FETAL SCALP SPIRAL ELECTRODE?

FETAL SCALP SPIRAL ELECTRODE is a medical device that received FDA 510(k) clearance on 1991-07-11. The listed applicant is Advanced Medical Systems, Inc.. The 510(k) number is K911657.

When did FETAL SCALP SPIRAL ELECTRODE receive FDA 510(k) clearance?

FETAL SCALP SPIRAL ELECTRODE received FDA 510(k) clearance on 1991-07-11, under 510(k) number K911657.

Who is the listed applicant for FETAL SCALP SPIRAL ELECTRODE?

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 FETAL SCALP SPIRAL ELECTRODE?

The FDA product code for FETAL SCALP SPIRAL ELECTRODE is HGP.

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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.

K955931MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION)K952031ULTRASOUND TRANSDUCER, MODEL US917K940898MODEL IM77 INTRAPARTUM FETAL MONITORK923335ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATIONK932278PFM PROFESSIONAL 7000 SPIROMETERK902190FETAL PULSE DETECTOR MODEL DOP-1

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Related Devices (Code: HGP)

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.

K243291Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)Neoventa Medical ABK030691FETAL SPIRAL ELECTRODE, MODEL FSE07000Clinical Innovations, Inc.K003458SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000Clinical Innovations, Inc.K943732LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCEGraphic Controls Corp.K910815CR SPIRAL ELECTRODENeward Enterprises, Inc.K905830COMBO FETAL SCALP ELECTRODE/LEGPLATEUtah Medical Products, 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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