SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09— 510(k) K032981

Substantially Equivalent

Invamed Technologies, Inc.

FDA 510(k) clearance K032981 for SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09, Substantially Equivalent on 2004-04-22. Applicant: Invamed Technologies, Inc..

Clearance details

Applicant: Invamed Technologies, Inc.
Product code: Code BSP
Advisory panel: Anesthesiology
Date received: 2003-09-24
Decision date: 2004-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, CO, US

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Adverse events under product code BSP

product code BSP

Death: 2
Total: 2

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.