PULSE MED CUSTOM PKG. PROC. TRAYS OPERATING ROOMS— 510(k) K851464

Substantially Equivalent

Pulse Med, Inc.

FDA 510(k) clearance K851464 for PULSE MED CUSTOM PKG. PROC. TRAYS OPERATING ROOMS, Substantially Equivalent on 1985-07-05. Applicant: Pulse Med, Inc..

Clearance details

Applicant: Pulse Med, Inc.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 1985-04-11
Decision date: 1985-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Ramon, CA, US

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Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.