Device Classification Name |
system, network and communication, physiological monitors
|
510(k) Number |
K192952 |
Device Name |
Spire Health Remote Patient Monitoring System |
Applicant |
Spire, Inc. d/b/a Spire Health |
2030 Harrison St |
San Francisco,
CA
94110
|
|
Applicant Contact |
Joanne Hollenbach |
Correspondent |
Enzyme Corporation |
360 Langton St, Ste 100 |
San Francisco,
CA
94103
|
|
Correspondent Contact |
Jared Seehafer |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 10/21/2019 |
Decision Date | 06/05/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|