MODEL 1301 BIOTAC (TM)— 510(k) K810627

Name: FDA 510(k) clearance K810627
Creator: U.S. Food and Drug Administration
Published: 1981-04-02

Substantially Equivalent

Progress Mankind Technology

FDA 510(k) clearance K810627 for MODEL 1301 BIOTAC (TM), Substantially Equivalent on 1981-04-02. Applicant: Progress Mankind Technology. Device class: 1.

Clearance details

Applicant: Progress Mankind Technology
Product code: Code GEA
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1981-03-09
Decision date: 1981-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hopkins, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GEA

product code GEA

Malfunction: 587
Total: 587

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.