Device Classification Name |
recorder, magnetic tape, medical
|
510(k) Number |
K220893 |
Device Name |
Strados Remote Electronic Stethoscope Platform (RESP) |
Applicant |
Strados Labs, Inc. |
1315 Walnut Street, Suite 1101 |
Philadelphia,
PA
19107
|
|
Applicant Contact |
Nicholas Delmonico |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 870.2800
|
Classification Product Code |
|
Date Received | 03/28/2022 |
Decision Date | 04/27/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|