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FDA 510(k)

EXTERNAL FETAL MONITOR TRANSDUCER HOLDER

K-Number: K905606 · 1991-03-12

ApplicantAtheus Corp.
Decision Date1991-03-12
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EXTERNAL FETAL MONITOR TRANSDUCER HOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Atheus Corp.. It received FDA 510(k) clearance on 1991-03-12 under 510(k) number K905606. 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 EXTERNAL FETAL MONITOR TRANSDUCER HOLDER?

EXTERNAL FETAL MONITOR TRANSDUCER HOLDER is a medical device that received FDA 510(k) clearance on 1991-03-12. The listed applicant is Atheus Corp.. The 510(k) number is K905606.

When did EXTERNAL FETAL MONITOR TRANSDUCER HOLDER receive FDA 510(k) clearance?

EXTERNAL FETAL MONITOR TRANSDUCER HOLDER received FDA 510(k) clearance on 1991-03-12, under 510(k) number K905606.

Who is the listed applicant for EXTERNAL FETAL MONITOR TRANSDUCER HOLDER?

The FDA 510(k) record lists Atheus Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXTERNAL FETAL MONITOR TRANSDUCER HOLDER?

The FDA product code for EXTERNAL FETAL MONITOR TRANSDUCER HOLDER 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 Atheus 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.

K893462NU-TRAP SUCTION CATHETER W/MUCUS TRAP

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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