Device Classification Name |
Ventilatory Effort Recorder
|
510(k) Number |
K140861 |
Device Name |
SOMNOTOUCH RESP |
Applicant |
SOMNOMEDICS GMBH |
AM SONNENSTUHL 63 |
RANDERSACKER,
DE
D-97236
|
|
Applicant Contact |
MATTHIAS BROENNER |
Correspondent |
SOMNOMEDICS GMBH |
AM SONNENSTUHL 63 |
RANDERSACKER,
DE
D-97236
|
|
Correspondent Contact |
MATTHIAS BROENNER |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 04/03/2014 |
Decision Date | 01/30/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|