MODEL 780
FDA 510(k) clearance K031383 · decided 2003-07-07
Clearance details
- K-number
- K031383
- Device name
- MODEL 780
- Applicant
- Hudson Respiratory Care, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-05-01
- Decision date
- 2003-07-07
- Days to decision
- 67 days
- Clearance type
- Special
- Product code
- BTT
- Device class
- 2
- Regulation number
- 868.5450
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Temecula, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heate recall (Z-0419-2016) | Teleflex Medical | 2015-12-15 |
| Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory Gas Humidifi recall (Z-2107-2014) | Teleflex Medical | 2014-07-23 |