PROSOLV ECHOVIEWER, PROSOLV ECHOVIEWER SE, PROSOLV ECHOANALYZER, PROSOLV ECHOSERV, PROSOLV ECHO— 510(k) K993750

Substantially Equivalent

Problem Solving Concepts, Inc.

FDA 510(k) clearance K993750 for PROSOLV ECHOVIEWER, PROSOLV ECHOVIEWER SE, PROSOLV ECHOANALYZER, PROSOLV ECHOSERV, PROSOLV ECHO, Substantially Equivalent on 2000-02-02. Applicant: Problem Solving Concepts, Inc..

Clearance details

Applicant: Problem Solving Concepts, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1999-11-05
Decision date: 2000-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carmel, IN, US

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.