Device Classification Name |
ingestible event marker
|
510(k) Number |
K183052 |
Device Name |
ID-Cap System |
Applicant |
etectRx, Inc. |
747 SW 2nd Ave Suite 365T, IMB 24 |
Gainesville,
FL
32601
|
|
Applicant Contact |
Susan Baumgartner |
Correspondent |
etectRx, Inc. |
747 SW 2nd Ave Suite 365T, IMB 24 |
Gainesville,
FL
32601
|
|
Correspondent Contact |
Paul Dryden |
Regulation Number | 880.6305
|
Classification Product Code |
|
Date Received | 11/02/2018 |
Decision Date | 12/06/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02344238 NCT02344251 NCT03475485 NCT03653897
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|