The following data is part of a premarket notification filed by Sparo Inc. with the FDA for Wing Smart Fevi And Peak Flow Meter.
| Device ID | K152276 |
| 510k Number | K152276 |
| Device Name: | Wing Smart FEVI And Peak Flow Meter |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | Sparo Inc. 911 Washington Ave, #809 Saint Louis, MO 63101 |
| Contact | Mona Dean |
| Correspondent | Mona Dean Sparo Inc. 911 Washington Ave, #809 Saint Louis, MO 63101 |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-12 |
| Decision Date | 2016-06-03 |
| Summary: | summary |