Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K992670 |
Device Name |
OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067 |
Applicant |
INSTRUMENTATION INDUSTRIES, INC. |
2990 INDUSTRIAL BLVD. |
BETHEL PARK,
PA
15102
|
|
Applicant Contact |
TRICIA WOOD |
Correspondent |
INSTRUMENTATION INDUSTRIES, INC. |
2990 INDUSTRIAL BLVD. |
BETHEL PARK,
PA
15102
|
|
Correspondent Contact |
TRICIA WOOD |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 06/21/1999 |
Decision Date | 09/17/1999 |
Decision |
SE SUBJECT TO TRACKING REG
(ST) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|