Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K791422 |
Device Name |
MINISPIROMETER SP-1 |
Applicant |
RENESCO INTERNATIONAL, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
RENESCO INTERNATIONAL, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 07/16/1979 |
Decision Date | 11/05/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|