Device Classification Name |
stethoscope, electronic
|
510(k) Number |
K223166 |
Device Name |
Medaica M1 Telehealth Stethoscope |
Applicant |
Medaica Inc. |
170 S. Green Valley Pkwy Ste 300 |
Henderson,
NV
89012
|
|
Applicant Contact |
Stephen Randall |
Correspondent |
THIRD PARTY REVIEW GROUP, LLC |
25 Independence Blvd |
Warren,
NJ
07059
|
|
Correspondent Contact |
Dave Yungvirt |
Regulation Number | 870.1875
|
Classification Product Code |
|
Date Received | 10/07/2022 |
Decision Date | 01/19/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|