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FDA 510(k)

SMI DIGITRON

K-Number: K840186 · 1984-04-05

Decision Date1984-04-05
Product CodeJRC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SMI DIGITRON is the device name listed in this FDA 510(k) record. The listed applicant is Scientific Manufacturing Industries. It received FDA 510(k) clearance on 1984-04-05 under 510(k) number K840186. The device is classified under product code JRC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMI DIGITRON?

SMI DIGITRON is a medical device that received FDA 510(k) clearance on 1984-04-05. The listed applicant is Scientific Manufacturing Industries. The 510(k) number is K840186.

When did SMI DIGITRON receive FDA 510(k) clearance?

SMI DIGITRON received FDA 510(k) clearance on 1984-04-05, under 510(k) number K840186.

Who is the listed applicant for SMI DIGITRON?

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

What is the FDA product code for SMI DIGITRON?

The FDA product code for SMI DIGITRON is JRC.

Related Clinical Trials

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.

Other records listing Scientific Manufacturing Industries as applicant

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.

Related Devices (Code: JRC)

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.

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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