ALTERNATING PRESSURE PUMP AND PAD SYSTEM— 510(k) K900871

Substantially Equivalent

Three Bears Intl.

FDA 510(k) clearance K900871 for ALTERNATING PRESSURE PUMP AND PAD SYSTEM, Substantially Equivalent on 1990-04-04. Applicant: Three Bears Intl..

Clearance details

Applicant: Three Bears Intl.
Product code: Code FNM
Advisory panel: General Hospital
Date received: 1990-02-24
Decision date: 1990-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Bedford, MA, 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.