GENERAL PROCEDURAL STRETCHERS (P880- P886)— 510(k) K922809
Substantially EquivalentHill-Rom, Inc.
FDA 510(k) clearance K922809 for GENERAL PROCEDURAL STRETCHERS (P880- P886), Substantially Equivalent on 1993-03-31. Applicant: Hill-Rom, Inc.. Device class: 2.
Clearance details
- Applicant
- Hill-Rom, Inc.
- Product code
- Code FPO
- Device class
- Class 2
- Regulation
- 21 CFR 880.6910
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Batesville, TN, US
Recent devices under product code FPO
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 FPO
product code FPO- Death
- 29
- Injury
- 254
- Malfunction
- 5,054
- Other
- 10
- Total
- 5,347
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.