SPIRO-BALL
Spirometer, Therapeutic (incentive)
LEVENTON, S.A.
The following data is part of a premarket notification filed by Leventon, S.a. with the FDA for Spiro-ball.
Pre-market Notification Details
| Device ID | K053149 |
| 510k Number | K053149 |
| Device Name: | SPIRO-BALL |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | LEVENTON, S.A. C/NEWTON 18-24, POLIGONO INDUSTRIAL SESROVIRES, SANT Esteve Sesrovires, Barcelona, ES 08635 |
| Contact | Oriol Vernis |
| Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-11-10 |
| Decision Date | 2005-12-13 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18436020761840 | K053149 | 000 |
Trademark Results [SPIRO-BALL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPIRO-BALL 79107544 4169867 Dead/Cancelled |
LEVENTON S.A. 2011-12-02 |
 SPIRO-BALL 75292230 not registered Dead/Abandoned |
Kennedy, Robert H. Sr. 1997-05-15 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.