Device Classification Name |
humidifier, respiratory gas, (direct patient interface)
|
510(k) Number |
K854363 |
Device Name |
SARATOGA SCT HEATED HUMIDIFICATION SYSTEM |
Applicant |
SARATOGA MEDICAL INSTRUMENTATION, INC. |
R.D. 1, BOX 131 |
HADLEY,
NY
12835
|
|
Applicant Contact |
JOHN KURAS |
Correspondent |
SARATOGA MEDICAL INSTRUMENTATION, INC. |
R.D. 1, BOX 131 |
HADLEY,
NY
12835
|
|
Correspondent Contact |
JOHN KURAS |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 10/29/1985 |
Decision Date | 12/31/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|