Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K101857 |
Device Name |
RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V |
Applicant |
INSTRUMENTATION INDUSTRIES, INC. |
2990 INDUSTRIAL BLVD. |
BETHEL PARK,
PA
15102
|
|
Applicant Contact |
DORIS F WALTER |
Correspondent |
INSTRUMENTATION INDUSTRIES, INC. |
2990 INDUSTRIAL BLVD. |
BETHEL PARK,
PA
15102
|
|
Correspondent Contact |
DORIS F WALTER |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 07/02/2010 |
Decision Date | 07/22/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|