MODEL 4000 ALTERNATING PRESSURE PUMP AND PAD— 510(k) K891259

Substantially Equivalent

Diamond Medical Equipment, Inc.

FDA 510(k) clearance K891259 for MODEL 4000 ALTERNATING PRESSURE PUMP AND PAD, Substantially Equivalent on 1989-11-17. Applicant: Diamond Medical Equipment, Inc..

Clearance details

Applicant: Diamond Medical Equipment, Inc.
Product code: Code FNM
Advisory panel: General Hospital
Date received: 1989-03-08
Decision date: 1989-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jamaica, 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.