Device Classification Name |
Spirometer, Diagnostic
|
510(k) Number |
K915451 |
Device Name |
MULTISPIRO-SX |
Applicant |
MULTISPIRO, INC. |
9A MASON |
IRVINE,
CA
92718
|
|
Applicant Contact |
DANIEL BROWN |
Correspondent |
MULTISPIRO, INC. |
9A MASON |
IRVINE,
CA
92718
|
|
Correspondent Contact |
DANIEL BROWN |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 12/05/1991 |
Decision Date | 07/02/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|