Device Classification Name |
Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
|
510(k) Number |
K001866 |
Device Name |
TCM400 |
Applicant |
RADIOMETER MEDICAL A/S |
AKANDEVEJ 21 |
DK-2700 BRONSHOJ,
DK
DK-2700
|
|
Applicant Contact |
KRISTEN RONO |
Correspondent |
RADIOMETER MEDICAL A/S |
AKANDEVEJ 21 |
DK-2700 BRONSHOJ,
DK
DK-2700
|
|
Correspondent Contact |
KRISTEN RONO |
Regulation Number | 868.2500
|
Classification Product Code |
|
Date Received | 06/20/2000 |
Decision Date | 12/07/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|