Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K844226 |
Device Name |
B-1000 |
Applicant |
BIOTRINE CORP. |
52 DRAGON CT |
WOBURN,
MA
01801
|
|
Applicant Contact |
JOHN W BURKE |
Correspondent |
BIOTRINE CORP. |
52 DRAGON CT |
WOBURN,
MA
01801
|
|
Correspondent Contact |
JOHN W BURKE |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 11/01/1984 |
Decision Date | 11/20/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|