Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K222525 |
Device Name |
Alveoair Digital Spirometer |
Applicant |
Roundworks Technologies Private Limited |
Office No. B 302, Building No. B, 3rd floor, GO Square, |
Survey No.249/250, Above Surya Electronic |
Wakad, Pune,
IN
411047
|
|
Applicant Contact |
Prashant Patel |
Correspondent |
IZiel Healthcare |
14, Hadapsar Industrial Estate, Hadapsar |
Pune,
IN
411013
|
|
Correspondent Contact |
Ankur Naik |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 08/22/2022 |
Decision Date | 08/28/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|