The following data is part of a premarket notification filed by Biotrine Corp. with the FDA for B-1000.
| Device ID | K844226 |
| 510k Number | K844226 |
| Device Name: | B-1000 |
| Classification | Spirometer, Diagnostic |
| 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 | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-01 |
| Decision Date | 1984-11-20 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() B-1000 73106470 1168521 Dead/Cancelled |
Yonex Sports Kabushiki Kaisha 1976-11-12 |