COMPUTRIM 900— 510(k) K800939

Substantially Equivalent

Amf, Inc.

FDA 510(k) clearance K800939 for COMPUTRIM 900, Substantially Equivalent on 1980-05-28. Applicant: Amf, Inc..

Clearance details

Applicant: Amf, Inc.
Product code: Code ISD
Advisory panel: Physical Medicine
Date received: 1980-04-22
Decision date: 1980-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code ISD

product code ISD

Other: 2
Total: 2

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.