MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701— 510(k) K043354

Substantially Equivalent

Invivo Research, Inc.

FDA 510(k) clearance K043354 for MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701, Substantially Equivalent on 2005-01-10. Applicant: Invivo Research, Inc..

Clearance details

Applicant: Invivo Research, Inc.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 2004-12-06
Decision date: 2005-01-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Orlando, FL, US

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Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.