Device Classification Name |
Spirometer, Monitoring (W/Wo Alarm)
|
510(k) Number |
K830995 |
Device Name |
POCKET SPIROMETER |
Applicant |
P.K. MORGAN INSTRUMENTS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
P.K. MORGAN INSTRUMENTS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 868.1850
|
Classification Product Code |
|
Date Received | 03/29/1983 |
Decision Date | 04/28/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|