PROXIMA 1 PH MONITOR— 510(k) K881706

Name: FDA 510(k) clearance K881706
Creator: U.S. Food and Drug Administration
Published: 1988-07-12

Substantially Equivalent

Technomanagement, Inc. C/O C.G.

FDA 510(k) clearance K881706 for PROXIMA 1 PH MONITOR, Substantially Equivalent on 1988-07-12. Applicant: Technomanagement, Inc. C/O C.G.. Device class: 1.

Clearance details

Applicant: Technomanagement, Inc. C/O C.G.
Product code: Code FFT
Device class: Class 1
Regulation: 21 CFR 876.1400
Advisory panel: Gastroenterology, Urology
Date received: 1988-04-19
Decision date: 1988-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Findley, MN, 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.