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FDA 510(k)

DIGITRON 3V,3VA,3VAC,3 HIGH RESOLUTION UPGRADE

K-Number: K861429 · 1986-07-25

ApplicantSiemens Gammasonics, Inc.
Decision Date1986-07-25
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITRON 3V,3VA,3VAC,3 HIGH RESOLUTION UPGRADE is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Gammasonics, Inc.. It received FDA 510(k) clearance on 1986-07-25 under 510(k) number K861429. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITRON 3V,3VA,3VAC,3 HIGH RESOLUTION UPGRADE?

DIGITRON 3V,3VA,3VAC,3 HIGH RESOLUTION UPGRADE is a medical device that received FDA 510(k) clearance on 1986-07-25. The listed applicant is Siemens Gammasonics, Inc.. The 510(k) number is K861429.

When did DIGITRON 3V,3VA,3VAC,3 HIGH RESOLUTION UPGRADE receive FDA 510(k) clearance?

DIGITRON 3V,3VA,3VAC,3 HIGH RESOLUTION UPGRADE received FDA 510(k) clearance on 1986-07-25, under 510(k) number K861429.

Who is the listed applicant for DIGITRON 3V,3VA,3VAC,3 HIGH RESOLUTION UPGRADE?

The FDA 510(k) record lists Siemens Gammasonics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIGITRON 3V,3VA,3VAC,3 HIGH RESOLUTION UPGRADE?

The FDA product code for DIGITRON 3V,3VA,3VAC,3 HIGH RESOLUTION UPGRADE is LLZ.

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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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