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)

TECHNA TONE

K-Number: K961082 · 1996-05-07

ApplicantTechna Tone
Decision Date1996-05-07
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TECHNA TONE is the device name listed in this FDA 510(k) record. The listed applicant is Techna Tone. It received FDA 510(k) clearance on 1996-05-07 under 510(k) number K961082. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECHNA TONE?

TECHNA TONE is a medical device that received FDA 510(k) clearance on 1996-05-07. The listed applicant is Techna Tone. The 510(k) number is K961082.

When did TECHNA TONE receive FDA 510(k) clearance?

TECHNA TONE received FDA 510(k) clearance on 1996-05-07, under 510(k) number K961082.

Who is the listed applicant for TECHNA TONE?

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

What is the FDA product code for TECHNA TONE?

The FDA product code for TECHNA TONE is ESD.

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.

Related Devices (Code: ESD)

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.

↑