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FDA 510(k)

ACUSON S328 TRANSDUCER FOR FETAL PULSED DOPPLER

K-Number: K884271 · 1989-07-27

ApplicantAcuson Corp.
Decision Date1989-07-27
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACUSON S328 TRANSDUCER FOR FETAL PULSED DOPPLER is the device name listed in this FDA 510(k) record. The listed applicant is Acuson Corp.. It received FDA 510(k) clearance on 1989-07-27 under 510(k) number K884271. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUSON S328 TRANSDUCER FOR FETAL PULSED DOPPLER?

ACUSON S328 TRANSDUCER FOR FETAL PULSED DOPPLER is a medical device that received FDA 510(k) clearance on 1989-07-27. The listed applicant is Acuson Corp.. The 510(k) number is K884271.

When did ACUSON S328 TRANSDUCER FOR FETAL PULSED DOPPLER receive FDA 510(k) clearance?

ACUSON S328 TRANSDUCER FOR FETAL PULSED DOPPLER received FDA 510(k) clearance on 1989-07-27, under 510(k) number K884271.

Who is the listed applicant for ACUSON S328 TRANSDUCER FOR FETAL PULSED DOPPLER?

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

What is the FDA product code for ACUSON S328 TRANSDUCER FOR FETAL PULSED DOPPLER?

The FDA product code for ACUSON S328 TRANSDUCER FOR FETAL PULSED DOPPLER is IYO.

Related Clinical Trials

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Other records listing Acuson 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.

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Related Devices (Code: IYO)

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.

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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