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FDA 510(k)

SOMATRON

K-Number: K831394 · 1983-06-08

ApplicantSomatron Co.
Decision Date1983-06-08
Product CodeJFB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SOMATRON is the device name listed in this FDA 510(k) record. The listed applicant is Somatron Co.. It received FDA 510(k) clearance on 1983-06-08 under 510(k) number K831394. The device is classified under product code JFB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOMATRON?

SOMATRON is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is Somatron Co.. The 510(k) number is K831394.

When did SOMATRON receive FDA 510(k) clearance?

SOMATRON received FDA 510(k) clearance on 1983-06-08, under 510(k) number K831394.

Who is the listed applicant for SOMATRON?

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

What is the FDA product code for SOMATRON?

The FDA product code for SOMATRON is JFB.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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