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 |