Device Classification Name |
Spirometer, Diagnostic
|
510(k) Number |
K002499 |
Device Name |
BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE |
Applicant |
BRENTWOOD MEDICAL TECHNOLOGY CORP. |
3300 FUJITA ST. |
TORRANCE,
CA
90505
|
|
Applicant Contact |
GLEN MIZELLE |
Correspondent |
BRENTWOOD MEDICAL TECHNOLOGY CORP. |
3300 FUJITA ST. |
TORRANCE,
CA
90505
|
|
Correspondent Contact |
GLEN MIZELLE |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 08/14/2000 |
Decision Date | 11/08/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|