Device Classification Name |
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
|
510(k) Number |
K791561 |
Device Name |
RESPIRATOR DISCONNECT ALARM VA-100 |
Applicant |
INTERSECT MEDICAL PRODUCTS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
INTERSECT MEDICAL PRODUCTS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 868.2600
|
Classification Product Code |
|
Date Received | 08/15/1979 |
Decision Date | 09/19/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|