TONOMITOR (TM) + SUMP— 510(k) K883234

Name: FDA 510(k) clearance K883234
Creator: U.S. Food and Drug Administration
Published: 1988-10-12

Substantially Equivalent

Tonometrics, Inc.

FDA 510(k) clearance K883234 for TONOMITOR (TM) + SUMP, Substantially Equivalent on 1988-10-12. Applicant: Tonometrics, Inc.. Device class: 1.

Clearance details

Applicant: Tonometrics, Inc.
Product code: Code FFT
Device class: Class 1
Regulation: 21 CFR 876.1400
Advisory panel: Gastroenterology, Urology
Date received: 1988-08-01
Decision date: 1988-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethesda, MD, US

Download summary PDF View on FDA.gov ↗

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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.