Device Classification Name |
transmitters and receivers, electrocardiograph, telephone
|
510(k) Number |
K201669 |
Device Name |
SimpleSENSE |
Applicant |
Nanowear Inc. |
53 Boerum Place, Suite 3F |
Brooklyn,
NY
11201
|
|
Applicant Contact |
Venkatesh Varadan |
Correspondent |
Graematter, Inc. |
1324 Clarkson Clayton Ctr, #332 |
St Louis,
MO
63011
|
|
Correspondent Contact |
Melissa Walker |
Regulation Number | 870.2920
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/19/2020 |
Decision Date | 11/06/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|