Device Classification Name |
conserver, oxygen
|
510(k) Number |
K051988 |
Device Name |
OXY-SERVE II OXYGEN CONSERVING REGULATOR |
Applicant |
SUPERIOR PRODUCTS, INC. |
3786 RIDGE RD. |
CLEVELAND,
OH
44144
|
|
Applicant Contact |
RONALD JOHNSTON |
Correspondent |
SUPERIOR PRODUCTS, INC. |
3786 RIDGE RD. |
CLEVELAND,
OH
44144
|
|
Correspondent Contact |
RONALD JOHNSTON |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 07/22/2005 |
Decision Date | 09/21/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|