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

Name: FDA 510(k) clearance K891259
Creator: U.S. Food and Drug Administration
Published: 1989-11-17

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.. Device class: 2.

Clearance details

Applicant: Diamond Medical Equipment, Inc.
Product code: Code FNM
Device class: Class 2
Regulation: 21 CFR 880.5550
Advisory panel: General Hospital
Date received: 1989-03-08
Decision date: 1989-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jamaica, NY, US

Download summary PDF View on FDA.gov ↗

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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.