Device Classification Name |
Monitor, Carbon-Dioxide, Cutaneous
|
510(k) Number |
K131253 |
Device Name |
PERIFLUX 6000 |
Applicant |
PERIMED AB |
DATAVAGEN 9 A |
JARFALLA,
SE
17543
|
|
Applicant Contact |
MARIA LILJEVRET |
Correspondent |
PERIMED AB |
DATAVAGEN 9 A |
JARFALLA,
SE
17543
|
|
Correspondent Contact |
MARIA LILJEVRET |
Regulation Number | 868.2480
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/02/2013 |
Decision Date | 10/22/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|