The following data is part of a premarket notification filed by Biotrine Corp. with the FDA for Peak Flow Monitor.
| Device ID | K813414 |
| 510k Number | K813414 |
| Device Name: | PEAK FLOW MONITOR |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | BIOTRINE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-07 |
| Decision Date | 1981-12-31 |