Device Classification Name |
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
|
510(k) Number |
K842374 |
Device Name |
NOVAMETRIX 850 TRANSCUTANEOUS OXYGEN |
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 | 06/18/1984 |
Decision Date | 09/17/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|