510(k) K993355
HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43 by
Hudson Respiratory Care, Inc.
— Product Code BTT
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 24, 2000
- Date Received
- October 6, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Humidifier, Respiratory Gas, (Direct Patient Interface)
- Device Class
- Class II
- Regulation Number
- 868.5450
- Review Panel
- AN
- Submission Type