Device Classification Name |
Generator, Oxygen, Portable
|
510(k) Number |
K861011 |
Device Name |
SILENT PARTNER MODEL 10-2001 |
Applicant |
MEDICAL DEVICES, INC. |
5000 DUFFERIN STREET, UNIT N |
DOWNSVIEW |
ONTARIO M3H 5T5,
CA
|
|
Applicant Contact |
STEVEN SERBER |
Correspondent |
MEDICAL DEVICES, INC. |
5000 DUFFERIN STREET, UNIT N |
DOWNSVIEW |
ONTARIO M3H 5T5,
CA
|
|
Correspondent Contact |
STEVEN SERBER |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 03/18/1986 |
Decision Date | 04/04/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|