PATIENT ISOLATOR #S-10/D-10— 510(k) K820566

Name: FDA 510(k) clearance K820566
Creator: U.S. Food and Drug Administration
Published: 1982-03-23

Substantially Equivalent

Microelectrodes, Inc.

FDA 510(k) clearance K820566 for PATIENT ISOLATOR #S-10/D-10, Substantially Equivalent on 1982-03-23. Applicant: Microelectrodes, Inc.. Device class: 1.

Clearance details

Applicant: Microelectrodes, Inc.
Product code: Code FFT
Device class: Class 1
Regulation: 21 CFR 876.1400
Advisory panel: Gastroenterology, Urology
Date received: 1982-03-02
Decision date: 1982-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FFT

product code FFT

Injury: 595
Malfunction: 2,175
Other: 1
Total: 2,771

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.