FDA 510(k)

ULTRASOUND IMAGING SYSTEM

K-Number: K780993 · 1978-08-10

Decision Date1978-08-10

Product CodeGAD

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ULTRASOUND IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1978-08-10 under 510(k) number K780993. The device is classified under product code GAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASOUND IMAGING SYSTEM?

ULTRASOUND IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1978-08-10. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K780993.

When did ULTRASOUND IMAGING SYSTEM receive FDA 510(k) clearance?

ULTRASOUND IMAGING SYSTEM received FDA 510(k) clearance on 1978-08-10, under 510(k) number K780993.

Who is the listed applicant for ULTRASOUND IMAGING SYSTEM?

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

What is the FDA product code for ULTRASOUND IMAGING SYSTEM?

The FDA product code for ULTRASOUND IMAGING SYSTEM is GAD.

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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.