Device Classification Name |
calculator, pulmonary function data
|
510(k) Number |
K892121 |
Device Name |
SPIRO-LINK REAL TIME SPIROMETRY SYSTEM |
Applicant |
BIOCOM INTL., INC. |
12201 133RD AVE. EAST |
PUYALLUP,
WA
98374
|
|
Applicant Contact |
DENNIS W WASSMAN |
Correspondent |
BIOCOM INTL., INC. |
12201 133RD AVE. EAST |
PUYALLUP,
WA
98374
|
|
Correspondent Contact |
DENNIS W WASSMAN |
Regulation Number | 868.1880
|
Classification Product Code |
|
Date Received | 03/31/1989 |
Decision Date | 06/16/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|