The following data is part of a premarket notification filed by Biotrine Corp. with the FDA for Multispiro Sa/100.
| Device ID | K863134 |
| 510k Number | K863134 |
| Device Name: | MULTISPIRO SA/100 |
| Classification | Spirometer, Diagnostic |
| Applicant | BIOTRINE CORP. 52 DRAGON CT Woburn, MA 01801 |
| Contact | John Burke |
| Correspondent | John Burke BIOTRINE CORP. 52 DRAGON CT Woburn, MA 01801 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-15 |
| Decision Date | 1986-12-15 |