TRI-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 Tri-ball.

Pre-market Notification Details

• Device ID: K994074
• 510k Number: K994074
• Device Name: TRI-BALL
• Classification: Spirometer, Therapeutic (incentive)
• Applicant: LEVENTON, S.A. POLIGONO CAN SUYER, 11 SANT ANDREU DE LA BARCA Barcelona, ES 08740
• Contact: Joaquim Soriano
• Correspondent: Joaquim Soriano; LEVENTON, S.A. POLIGONO CAN SUYER, 11 SANT ANDREU DE LA BARCA Barcelona, ES 08740
• Product Code: BWF
• CFR Regulation Number: 868.5690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-12-02
• Decision Date: 2000-06-08

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
18436020761833	K994074	000