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FDA 510(k)

FETAL MONITORING TRANSDUCER STRAP

K-Number: K902802 · 1990-09-04

ApplicantMacon & Co., Inc.
Decision Date1990-09-04
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FETAL MONITORING TRANSDUCER STRAP is the device name listed in this FDA 510(k) record. The listed applicant is Macon & Co., Inc.. It received FDA 510(k) clearance on 1990-09-04 under 510(k) number K902802. 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 FETAL MONITORING TRANSDUCER STRAP?

FETAL MONITORING TRANSDUCER STRAP is a medical device that received FDA 510(k) clearance on 1990-09-04. The listed applicant is Macon & Co., Inc.. The 510(k) number is K902802.

When did FETAL MONITORING TRANSDUCER STRAP receive FDA 510(k) clearance?

FETAL MONITORING TRANSDUCER STRAP received FDA 510(k) clearance on 1990-09-04, under 510(k) number K902802.

Who is the listed applicant for FETAL MONITORING TRANSDUCER STRAP?

The FDA 510(k) record lists Macon & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FETAL MONITORING TRANSDUCER STRAP?

The FDA product code for FETAL MONITORING TRANSDUCER STRAP 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 Macon & Co., 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.

K800103SURGICAL STITCH CUTTER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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