Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K843996 |
Device Name |
TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER |
Applicant |
EQUILIBRATED BIO SYSTEMS, INC. |
900 WALT WHITMAN RD. |
MELVILLE,
NY
11747
|
|
Applicant Contact |
ALEX STENZLER |
Correspondent |
EQUILIBRATED BIO SYSTEMS, INC. |
900 WALT WHITMAN RD. |
MELVILLE,
NY
11747
|
|
Correspondent Contact |
ALEX STENZLER |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 10/11/1984 |
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
|
|
|