Device Classification Name |
Ventilatory Effort Recorder
|
510(k) Number |
K173974 |
Device Name |
DROWZLE |
Applicant |
Resonea, Inc. |
11445 E Via Linda |
Suite 24 |
Scottsdale,
AZ
85259
|
|
Applicant Contact |
Ruchir Sehra |
Correspondent |
Graematter Inc |
1324 Clarkson Clayton Center |
#332 |
St Louis,
MO
63011
|
|
Correspondent Contact |
Melissa Walker |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 12/29/2017 |
Decision Date | 07/14/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT03288376
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|