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FDA 510(k)

ULTRASOUND BREAST SCANNING DEVICE

K-Number: K781177 · 1979-01-03

ApplicantLife Instrument Corp.
Decision Date1979-01-03
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRASOUND BREAST SCANNING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Life Instrument Corp.. It received FDA 510(k) clearance on 1979-01-03 under 510(k) number K781177. 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 ULTRASOUND BREAST SCANNING DEVICE?

ULTRASOUND BREAST SCANNING DEVICE is a medical device that received FDA 510(k) clearance on 1979-01-03. The listed applicant is Life Instrument Corp.. The 510(k) number is K781177.

When did ULTRASOUND BREAST SCANNING DEVICE receive FDA 510(k) clearance?

ULTRASOUND BREAST SCANNING DEVICE received FDA 510(k) clearance on 1979-01-03, under 510(k) number K781177.

Who is the listed applicant for ULTRASOUND BREAST SCANNING DEVICE?

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

What is the FDA product code for ULTRASOUND BREAST SCANNING DEVICE?

The FDA product code for ULTRASOUND BREAST SCANNING DEVICE is IYO.

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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.

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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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