The following data is part of a premarket notification filed by Raiinbow Step Up Systems, Inc. with the FDA for Rainbow Step Up Systems Inc. Asthma Home Care Plan.
| Device ID | K953458 |
| 510k Number | K953458 |
| Device Name: | RAINBOW STEP UP SYSTEMS INC. ASTHMA HOME CARE PLAN |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | RAIINBOW STEP UP SYSTEMS, INC. 555 TURNPIKE ST. North Andover, MA 01845 |
| Contact | Melissa A Thompson |
| Correspondent | Melissa A Thompson RAIINBOW STEP UP SYSTEMS, INC. 555 TURNPIKE ST. North Andover, MA 01845 |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-21 |
| Decision Date | 1995-11-17 |