Device Classification Name |
oximeter
|
510(k) Number |
K143216 |
Device Name |
Assurance Alar / Nasal SpO2 Sensor |
Applicant |
Xhale, Inc. |
3630 SW 47th Ave, Suite 100 |
Gainesville,
FL
32608
|
|
Applicant Contact |
Jeffrey Hoebelheinrich |
Correspondent |
Xhale, Inc. |
3630 SW 47th Ave, Suite 100 |
Gainesville,
FL
32608
|
|
Correspondent Contact |
Paul Dryden |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 11/10/2014 |
Decision Date | 03/17/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|