Device Classification Name |
meter, peak flow, spirometry
|
510(k) Number |
K193311 |
Device Name |
Aluna |
Applicant |
Knox Medical Diagnostics, Inc. |
345 California Street, Suite 600 |
San Francisco,
CA
94104
|
|
Applicant Contact |
Charvi Shetty |
Correspondent |
Acknowledge Regulatory Strategies |
2251 San Diego Ave, Suite B-257 |
San Diego,
CA
92110
|
|
Correspondent Contact |
Pierre Bounaud |
Regulation Number | 868.1860
|
Classification Product Code |
|
Date Received | 11/29/2019 |
Decision Date | 03/25/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|