Device Classification Name |
ventilatory effort recorder
|
510(k) Number |
K173793 |
Device Name |
XactTrace Single Use Respiratory Effort Belt System |
Applicant |
Embla Systems |
1 Hines Road, Suite 202 |
Kanata,
CA
K2K 3C7
|
|
Applicant Contact |
Sanjay Mehta |
Correspondent |
Embla Systems |
1 Hines Road, Suite 202 |
Kanata,
CA
k2k 3C7
|
|
Correspondent Contact |
Sanjay Mehta |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 12/14/2017 |
Decision Date | 03/01/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|