Device Classification Name |
ventilator, non-continuous (respirator)
|
510(k) Number |
K771217 |
Device Name |
ANESTHESIA RESPIRATOR |
Applicant |
RULE MEDICAL INSTRUMENTS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
RULE MEDICAL INSTRUMENTS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 07/05/1977 |
Decision Date | 08/04/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|