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FDA 510(k)

DIGITRON

K-Number: K812721 · 1981-11-04

ApplicantSiemens Corp.
Decision Date1981-11-04
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITRON is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Corp.. It received FDA 510(k) clearance on 1981-11-04 under 510(k) number K812721. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITRON?

DIGITRON is a medical device that received FDA 510(k) clearance on 1981-11-04. The listed applicant is Siemens Corp.. The 510(k) number is K812721.

When did DIGITRON receive FDA 510(k) clearance?

DIGITRON received FDA 510(k) clearance on 1981-11-04, under 510(k) number K812721.

Who is the listed applicant for DIGITRON?

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

What is the FDA product code for DIGITRON?

The FDA product code for DIGITRON is IZI.

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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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