HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43
FDA 510(k) clearance K993355 · decided 2000-05-24
Clearance details
- K-number
- K993355
- Device name
- HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43
- Applicant
- Hudson Respiratory Care, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-10-06
- Decision date
- 2000-05-24
- Days to decision
- 231 days
- Clearance type
- Traditional
- 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, Humidifier Adaptor, Rx only, Teleflex Medical, Research Triangle Park, NC 2770 recall (Z-2790-2011) | Teleflex Medical | 2011-07-12 |