MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701— 510(k) K043354
Substantially EquivalentInvivo 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.. Device class: 2.
Clearance details
- Applicant
- Invivo Research, Inc.
- Product code
- Code DRT
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- 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, through . 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.