510(k) K133604— ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS

Substantially Equivalent

The Anspach Effort, Inc.

Clearance details

Applicant: The Anspach Effort, Inc.
Product code: Code HBC
Advisory panel: Neurology
Date received: 2013-11-25
Decision date: 2014-01-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Palm Beach Gardens, FL, US

Adverse events under product code HBC

product code HBC

Malfunction: 4,715
Total: 4,715

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.