Device Classification Name |
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
|
510(k) Number |
K792516 |
Device Name |
RESPIRATOR DISCONNECT ALARM CR 201 |
Applicant |
INTERSECT MEDICAL PRODUCTS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
INTERSECT MEDICAL PRODUCTS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 868.2600
|
Classification Product Code |
|
Date Received | 12/05/1979 |
Decision Date | 01/09/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|