Device Classification Name |
Generator, Oxygen, Portable
|
510(k) Number |
K043615 |
Device Name |
OXYTEC, MODEL 900 |
Applicant |
OXYTEC MEDICAL CORPORATION |
6329 W. WATERVIEW CT. |
MCCORDSVILLE,
IN
46055 -9501
|
|
Applicant Contact |
PAUL E DRYDEN |
Correspondent |
OXYTEC MEDICAL CORPORATION |
6329 W. WATERVIEW CT. |
MCCORDSVILLE,
IN
46055 -9501
|
|
Correspondent Contact |
PAUL E DRYDEN |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 12/30/2004 |
Decision Date | 02/09/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|