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FDA 510(k)

FETAL ASSESSMENT CAP

K-Number: K992580 · 1999-10-18

ApplicantAcuson Corp.
Decision Date1999-10-18
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FETAL ASSESSMENT CAP is the device name listed in this FDA 510(k) record. The listed applicant is Acuson Corp.. It received FDA 510(k) clearance on 1999-10-18 under 510(k) number K992580. 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 FETAL ASSESSMENT CAP?

FETAL ASSESSMENT CAP is a medical device that received FDA 510(k) clearance on 1999-10-18. The listed applicant is Acuson Corp.. The 510(k) number is K992580.

When did FETAL ASSESSMENT CAP receive FDA 510(k) clearance?

FETAL ASSESSMENT CAP received FDA 510(k) clearance on 1999-10-18, under 510(k) number K992580.

Who is the listed applicant for FETAL ASSESSMENT CAP?

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 FETAL ASSESSMENT CAP?

The FDA product code for FETAL ASSESSMENT CAP is IYO.

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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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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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