CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM— 510(k) K040195
Substantially EquivalentWitt Biomedical Corp
FDA 510(k) clearance K040195 for CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM, Substantially Equivalent on 2004-04-07. Applicant: Witt Biomedical Corp. Device class: 2.
Clearance details
- Applicant
- Witt Biomedical Corp
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Melbourne, FL, US
Recent devices under product code LLZ
view allMore clearances from Witt Biomedical Corp
view all- K101571 — XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS
- K063840 — XPER INFORMATION MANAGEMENT/PHYSIOMONITORING 5 SYSTEM AND/OR VASCULAR 5, PATIENT CARE CONSOLE AND CENTRAL STATION
- K063547 — CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM
- K033030 — CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG MANAGEMENT SYSTEM
Adverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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.