The following data is part of a premarket notification filed by Multispiro, Inc. with the FDA for Multispiro-breeze.
| Device ID | K913681 |
| 510k Number | K913681 |
| Device Name: | MULTISPIRO-BREEZE |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | MULTISPIRO, INC. 9A MASON Irvine, CA 92718 |
| Contact | Daniel Brown |
| Correspondent | Daniel Brown MULTISPIRO, INC. 9A MASON Irvine, CA 92718 |
| Product Code | BZC |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-19 |
| Decision Date | 1992-07-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MULTISPIRO-BREEZE 74125396 1769218 Dead/Cancelled |
MULTISPIRO, INC. 1990-12-21 |