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)

ACU-DOT

K-Number: K781672 · 1978-11-08

ApplicantAcu-Dot Pharmaceutical Intl., Inc.
Decision Date1978-11-08
Product Code
DecisionSubstantially Equivalent

Device Summary

ACU-DOT is the device name listed in this FDA 510(k) record. The listed applicant is Acu-Dot Pharmaceutical Intl., Inc.. It received FDA 510(k) clearance on 1978-11-08 under 510(k) number K781672. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACU-DOT?

ACU-DOT is a medical device that received FDA 510(k) clearance on 1978-11-08. The listed applicant is Acu-Dot Pharmaceutical Intl., Inc.. The 510(k) number is K781672.

When did ACU-DOT receive FDA 510(k) clearance?

ACU-DOT received FDA 510(k) clearance on 1978-11-08, under 510(k) number K781672.

Who is the listed applicant for ACU-DOT?

The FDA 510(k) record lists Acu-Dot Pharmaceutical Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

↑