THE ADVANCE SERIES FROM HILL-ROM— 510(k) K922352
Substantially EquivalentHill-Rom, Inc.
FDA 510(k) clearance K922352 for THE ADVANCE SERIES FROM HILL-ROM, Substantially Equivalent on 1992-10-13. Applicant: Hill-Rom, Inc.. Device class: 2.
Clearance details
- Applicant
- Hill-Rom, Inc.
- Product code
- Code FNL
- Device class
- Class 2
- Regulation
- 21 CFR 880.5100
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Batesville, TN, US
Recent devices under product code FNL
view allMore clearances from Hill-Rom, Inc.
view all- K260211 — Dashboard (P007000)
- K202018 — Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation
- K180079 — Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation
- K013709 — HILL-ROM PRIMAVIEW MONITOR SYSTEM
- K973705 — CONTOR TABLE SURFACE
Adverse events under product code FNL
product code FNL- Death
- 64
- Injury
- 728
- Malfunction
- 10,825
- Other
- 9
- Total
- 11,626
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.