The following data is part of a premarket notification filed by Biotrine Corp. with the FDA for Astech Home Peak Flow Meter.
| Device ID | K915060 |
| 510k Number | K915060 |
| Device Name: | ASTECH HOME PEAK FLOW METER |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | BIOTRINE CORP. 52 DRAGON CT Woburn, MA 01801 |
| Contact | John W.burke |
| Correspondent | John W.burke BIOTRINE CORP. 52 DRAGON CT Woburn, MA 01801 |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-08 |
| Decision Date | 1992-09-11 |