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 |