VPAP Adapt SV, VPAP Tx, S9 VPAP Tx
FDA 510(k) clearance K161487 · decided 2016-09-09
Clearance details
- K-number
- K161487
- Device name
- VPAP Adapt SV, VPAP Tx, S9 VPAP Tx
- Applicant
- Resmed, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2016-05-31
- Decision date
- 2016-09-09
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- MNS
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Bella Vista, AU
- Third-party review
- No
- Expedited review
- No
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| ReddyPort NIV Access Elbow (K171827) | Smd Manufacturing, LLC | 2018-01-19 |
| Juno VPAP ST-A (K161492) | Resmed, Ltd. | 2017-01-19 |
| Juno VPAP ST-A (K153061) | Resmed, Ltd. | 2016-04-13 |
| EASYCARE ONLINE (K132371) | Resmed, Ltd. | 2013-11-22 |
| S9 VPAP TX (K123511) | Resmed, Ltd. | 2013-03-21 |
| EASYCARE ONLINE (K123557) | Resmed, Ltd. | 2013-03-14 |
Recalls involving this device
No recalls on record reference this clearance.