PHYSIO/1000— 510(k) K974070

Substantially Equivalent

Physio Designs, Inc.

FDA 510(k) clearance K974070 for PHYSIO/1000, Substantially Equivalent on 1998-01-06. Applicant: Physio Designs, Inc..

Clearance details

Applicant: Physio Designs, Inc.
Product code: Code FNM
Advisory panel: General Hospital
Date received: 1997-10-28
Decision date: 1998-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Commack, NY, US

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Adverse events under product code FNM

product code FNM

Death: 22
Injury: 349
Other: 4
Total: 375

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.