Device Classification Name |
Calculator, Pulmonary Function Interpretor (Diagnostic)
|
510(k) Number |
K012387 |
Device Name |
STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM |
Applicant |
STETHOGRAPHICS, INC. |
11874 S. EVELYN CIRCLE |
HOUSTON,
TX
77071
|
|
Applicant Contact |
HARVEY KNAUSS |
Correspondent |
STETHOGRAPHICS, INC. |
11874 S. EVELYN CIRCLE |
HOUSTON,
TX
77071
|
|
Correspondent Contact |
HARVEY KNAUSS |
Regulation Number | 868.1900
|
Classification Product Code |
|
Date Received | 07/27/2001 |
Decision Date | 04/23/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|