Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K203126 |
Device Name |
S10 Kirra |
Applicant |
ResMed Pty Ltd |
1 Elizabeth Macarthur Drive |
Bella Vista,
AU
2053
|
|
Applicant Contact |
Peter Jennings |
Correspondent |
ResMed Corp |
9001 Spectrum Center Boulevard |
San Diego,
CA
92123
|
|
Correspondent Contact |
Sheila Bruschi |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 10/19/2020 |
Decision Date | 12/18/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|