FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43
K Number: K993355
·
Decision May 24, 2000
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
220
Applicant Total
15
Review Days
231
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Basic Information
- Device Name
- HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43
- K Number
- K993355
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5450
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hudson Respiratory Care, Inc.
- Date Received
- October 6, 1999
- Decision Date
- May 24, 2000
- Product Code
- BTT
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | FDA class 2 | Anesthesiology |
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FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Hudson Respiratory Care, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K031383 | MODEL 780 | Jul 7, 2003 | Substantially Equivalent |
| K011134 | OXYGEN SUPPLY TUBING, MODEL 1115 | Jun 13, 2001 | Substantially Equivalent |
| K011125 | NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI | Jun 13, 2001 | Substantially Equivalent |
| K010402 | SMOOTH-FLO CIRCUIT | Mar 14, 2001 | Substantially Equivalent |
| K001213 | CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60 | Nov 3, 2000 | Substantially Equivalent |
| K994352 | SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896 | Mar 22, 2000 | Substantially Equivalent |
| K964719 | HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR | Feb 21, 1997 | Substantially Equivalent |
| K961150 | DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULA | Sep 10, 1996 | Substantially Equivalent |
| K961914 | BACTERIA/VIRAL FILTER | Aug 14, 1996 | Substantially Equivalent |
| K955645 | CATH-GUIDE | Mar 12, 1996 | Substantially Equivalent |