Device Classification Name |
monitor, physiological, patient (without arrhythmia detection or alarms)
|
510(k) Number |
K133810 |
Device Name |
VC150 VITAL SIGNS MONITOR |
Applicant |
INNOKAS YHTYMA |
TARJUSOJANTIE 12 |
KEMPELE, OULU,
FI
90440
|
|
Applicant Contact |
Tiina Kotipalo |
Correspondent |
INNOKAS YHTYMA |
TARJUSOJANTIE 12 |
KEMPELE, OULU,
FI
90440
|
|
Correspondent Contact |
Tiina Kotipalo |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 12/16/2013 |
Decision Date | 10/30/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|