Device Classification Name |
stethoscope, electronic
|
510(k) Number |
K220196 |
Device Name |
Steth IO Spot |
Applicant |
StratoScientific |
19125 North Creek Pkwy #120 |
Bothell,
WA
98011
|
|
Applicant Contact |
Mahesh Mulumudi |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 870.1875
|
Classification Product Code |
|
Date Received | 01/24/2022 |
Decision Date | 03/24/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|