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 |