Device Classification Name |
monitor, oxygen, cutaneous, for infant not under gas anesthesia
|
510(k) Number |
K791152 |
Device Name |
TCO2M MODEL 818 |
Applicant |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 868.2500
|
Classification Product Code |
|
Date Received | 06/19/1979 |
Decision Date | 08/03/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|