Device Classification Name |
Spirometer, Diagnostic
|
510(k) Number |
K851135 |
Device Name |
SPIRO SCAN |
Applicant |
BRENTWOOD INSTRUMENTS, INC. |
2909 OREGON COURT |
TORRANCE,
CA
90503
|
|
Applicant Contact |
JAMES OBERMAYER |
Correspondent |
BRENTWOOD INSTRUMENTS, INC. |
2909 OREGON COURT |
TORRANCE,
CA
90503
|
|
Correspondent Contact |
JAMES OBERMAYER |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 03/21/1985 |
Decision Date | 07/01/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|