Device Classification Name |
Oximeter
|
510(k) Number |
K222597 |
Device Name |
BabySat 3 |
Applicant |
Owlet Baby Care, Inc. |
3300 Ashton Blvd. Suite 300 |
Lehi,
UT
84043
|
|
Applicant Contact |
Tammy Lavery |
Correspondent |
ProMedic Consulting LLC |
131 Bay Point Dr NE |
St. Petersburg,
FL
33704
|
|
Correspondent Contact |
Paul Dryden |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 08/29/2022 |
Decision Date | 06/16/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|