Device Classification Name |
Meter, Peak Flow, Spirometry
|
510(k) Number |
K953458 |
Device Name |
RAINBOW STEP UP SYSTEMS INC. ASTHMA HOME CARE PLAN |
Applicant |
RAIINBOW STEP UP SYSTEMS, INC. |
555 TURNPIKE ST. |
NORTH ANDOVER,
MA
01845
|
|
Applicant Contact |
MELISSA A THOMPSON |
Correspondent |
RAIINBOW STEP UP SYSTEMS, INC. |
555 TURNPIKE ST. |
NORTH ANDOVER,
MA
01845
|
|
Correspondent Contact |
MELISSA A THOMPSON |
Regulation Number | 868.1860
|
Classification Product Code |
|
Date Received | 07/21/1995 |
Decision Date | 11/17/1995 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|