FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES
K Number: K093070
·
Decision Jan 26, 2010
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
46
Applicant Total
14
Review Days
118
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Basic Information
- Device Name
- DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES
- K Number
- K093070
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sunrise Medical
- Date Received
- September 30, 2009
- Decision Date
- January 26, 2010
- Product Code
- MNS
- 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 |
|---|---|---|---|
| MNS | Ventilator, Continuous, Non-Life-Supporting | FDA class 2 | Anesthesiology |
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|---|---|---|---|
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| K060531 | QUICKIE RHYTHM & GROOVE SERIES POWER WHEELCHAIRS W/QUICKIE DELPHI CONTROLS | Mar 17, 2006 | Substantially Equivalent |
| K053240 | DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES | Feb 3, 2006 | Substantially Equivalent |
| K043435 | QUICKIE INTERCHANGE FWD W/LIFT POWER WHEELCHAIR | Feb 11, 2005 | Substantially Equivalent |
| K043282 | DEVILBISS AUTOADJUST, MODEL 9054 SERIES | Feb 11, 2005 | Substantially Equivalent |