Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SMAC SYSTEM

K-Number: K770508 · 1977-05-09

Decision Date1977-05-09
Product CodeJCC
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

SMAC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mid Tech, Inc.. It received FDA 510(k) clearance on 1977-05-09 under 510(k) number K770508. The device is classified under product code JCC. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMAC SYSTEM?

SMAC SYSTEM is a medical device that received FDA 510(k) clearance on 1977-05-09. The listed applicant is Mid Tech, Inc.. The 510(k) number is K770508.

When did SMAC SYSTEM receive FDA 510(k) clearance?

SMAC SYSTEM received FDA 510(k) clearance on 1977-05-09, under 510(k) number K770508.

Who is the listed applicant for SMAC SYSTEM?

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

What is the FDA product code for SMAC SYSTEM?

The FDA product code for SMAC SYSTEM is JCC.

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 Mid Tech, Inc. 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: JCC)

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

View on FDA Database →

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

↑