Device Classification Name |
spirometer, monitoring (w/wo alarm)
|
510(k) Number |
K780064 |
Device Name |
SPIROMETER, MONITORING W/ALARM |
Applicant |
OHIO MEDICAL PRODUCTS |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
OHIO MEDICAL PRODUCTS |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 868.1850
|
Classification Product Code |
|
Date Received | 01/12/1978 |
Decision Date | 01/31/1978 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|