Triball Incentive Spirometer

510(k) Number

K133873 ↗

FDA product code

BWF

FDA applicant

Besmed Health Business Corp

Device class

Class II

Regulation

21 CFR Part 868.5690

Advisory committee

Anesthesiology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code BWF (Spirometer, Therapeutic (Incentive)).

• INSPIROMETER by Kinetix
• BUNN VOLUMAIRE RESPIRATORY EXERCISER by The John Bunn Co.
• PARI PEP THERAPY SYSTEM by Pari Holding Co.
• THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORT by Diemolding Corp.
• K-MED ENCOURAGER INCENTIVE SPIROMETER by K-Med, Inc.
• INSPIRATORY/EXPIRATORY MUSCLE EXERCIS by Inspiron Corp.
• INCENTIVE SPIROMETER by Engineered Medical Systems, LLC
• Combined Aerobika OPEP and VersaPAP device by TRUDELL MEDICAL INTERNATIONAL
• ELECATH INFANT ARTERIAL & VENOUS CANNU by Electro-Catheter Corp.
• Pulsehaler by Respinova, Ltd.

• Soft Guedel Airway, Size 30mm (Clear)

  Class I

  CE/MDR

• Oropharyngeal Airway for Fibre Fibre-Optic Intubation Intubation, Size 90mm

  Class I

  CE/MDR

• Silicone Drainage Tube, Fluted, Flat, 7mm, Trocar

  Class IIa

  CE/MDR

• Silicone Penrose tube, Round, OD:12mm, L:300mm

  Class IIa

  CE/MDR

See all devices from Besmed Health Business Corp. →