SURGICAL DESIGN CORPORATION MODEL 700 LOW PRESSURE MATTRESS— 510(k) K934817

Substantially Equivalent

Surgical Design Corp.

FDA 510(k) clearance K934817 for SURGICAL DESIGN CORPORATION MODEL 700 LOW PRESSURE MATTRESS, Substantially Equivalent on 1994-06-17. Applicant: Surgical Design Corp..

Clearance details

Applicant: Surgical Design Corp.
Product code: Code FNM
Advisory panel: General Hospital
Date received: 1993-10-05
Decision date: 1994-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.