Device Classification Name |
oximeter
|
510(k) Number |
K200537 |
Device Name |
Oxxiom |
Applicant |
True Wearables, Inc. |
29826 Avenida de Las Banderas, Suite 300 |
Rancho Santa Margarita,
CA
92688
|
|
Applicant Contact |
Marcelo Lamego |
Correspondent |
Gardner Law, PLLC |
423 Main Street |
Stillwater,
MN
55082
|
|
Correspondent Contact |
Amy Fowler |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 03/03/2020 |
Decision Date | 07/03/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|