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)

FRANTZ MEDICAL ELECTRODE

K-Number: K863508 · 1987-02-06

Decision Date1987-02-06
Product CodeDXR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FRANTZ MEDICAL ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Frantz Medical Development, Ltd.. It received FDA 510(k) clearance on 1987-02-06 under 510(k) number K863508. The device is classified under product code DXR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRANTZ MEDICAL ELECTRODE?

FRANTZ MEDICAL ELECTRODE is a medical device that received FDA 510(k) clearance on 1987-02-06. The listed applicant is Frantz Medical Development, Ltd.. The 510(k) number is K863508.

When did FRANTZ MEDICAL ELECTRODE receive FDA 510(k) clearance?

FRANTZ MEDICAL ELECTRODE received FDA 510(k) clearance on 1987-02-06, under 510(k) number K863508.

Who is the listed applicant for FRANTZ MEDICAL ELECTRODE?

The FDA 510(k) record lists Frantz Medical Development, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FRANTZ MEDICAL ELECTRODE?

The FDA product code for FRANTZ MEDICAL ELECTRODE is DXR.

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 Frantz Medical Development, Ltd. 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: DXR)

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.

↑