Device Classification Name |
computer, oxygen-uptake
|
510(k) Number |
K854927 |
Device Name |
ICOR CALARIC MEASUREMENT UNIT (CMU) |
Applicant |
ICOR AB |
ULVSUNDAVAGEN 178 B |
BROMMA,
SE
161 30
|
|
Applicant Contact |
GEDEON, PH.D. |
Correspondent |
ICOR AB |
ULVSUNDAVAGEN 178 B |
BROMMA,
SE
161 30
|
|
Correspondent Contact |
GEDEON, PH.D. |
Regulation Number | 868.1730
|
Classification Product Code |
|
Date Received | 12/10/1985 |
Decision Date | 03/27/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|