FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV
K Number: K160822
·
Decision Sep 9, 2016
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
459
Applicant Total
103
Review Days
169
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Basic Information
- Device Name
- S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV
- K Number
- K160822
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Resmed, Ltd.
- Date Received
- March 24, 2016
- Decision Date
- September 9, 2016
- Product Code
- BZD
- 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 |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | FDA class 2 | Anesthesiology |
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Other Clearances by Resmed, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K183512 | Moore Park Mask | May 7, 2019 | Substantially Equivalent |
| K180497 | Scone Mask | Jun 15, 2018 | Substantially Equivalent |
| K172875 | Astral 100/150 | Apr 26, 2018 | Substantially Equivalent |
| K170924 | AirFit F20 | Jan 3, 2018 | Substantially Equivalent |
| K171212 | AirFit N20 | Sep 28, 2017 | Substantially Equivalent |
| K161492 | Juno VPAP ST-A | Jan 19, 2017 | Substantially Equivalent |
| K160836 | Menai System | Dec 15, 2016 | Substantially Equivalent |
| K161978 | AirFit N20 | Nov 17, 2016 | Substantially Equivalent |
| K161487 | VPAP Adapt SV, VPAP Tx, S9 VPAP Tx | Sep 9, 2016 | Substantially Equivalent |
| K152068 | Astral 100/150 | May 13, 2016 | Substantially Equivalent |