Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K162753 |
Device Name |
RTC 26-C Inline Aerosol Adapter |
Applicant |
INSTRUMENTATION INDUSTRIES, INC. |
2990 INDUSTRIAL BLVD. |
BETHEL PARK,
PA
15102
|
|
Applicant Contact |
Doris Walter |
Correspondent |
INSTRUMENTATION INDUSTRIES, INC. |
2990 INDUSTRIAL BLVD. |
BETHEL PARK,
PA
15102
|
|
Correspondent Contact |
Doris Walter |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 09/30/2016 |
Decision Date | 02/28/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|