Device Classification Name |
spirometer, monitoring (w/wo alarm)
|
510(k) Number |
K903674 |
Device Name |
MODEL 295 ELECTRONIC RESPIROMETER |
Applicant |
NATIONAL MEDICAL SALES, INC. |
26086 GETTY |
LAGUNA NIQUEL,
CA
92677
|
|
Applicant Contact |
WILLIAM D BURCH |
Correspondent |
NATIONAL MEDICAL SALES, INC. |
26086 GETTY |
LAGUNA NIQUEL,
CA
92677
|
|
Correspondent Contact |
WILLIAM D BURCH |
Regulation Number | 868.1850
|
Classification Product Code |
|
Date Received | 08/13/1990 |
Decision Date | 01/04/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|