Triball Incentive Spirometer
FDA 510(k) K133873 · Besmed Health Business Corp
510(k) numberK133873
Submission
- Device name
- Triball Incentive Spirometer
- Applicant
- Besmed Health Business Corp
New Taipei City, Wu-Ku District, TW - Received
- December 20, 2013
- Decision date
- April 4, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BWF – Spirometer, Therapeutic (Incentive)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5690
- Specialty
- Anesthesiology
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| K143150 | CO2 monitoring line with and without in-line filterCCK · Traditional | 02/05/2015SE |
| K141355 | Volumetric Incentive SpirometerBWF · Traditional | 09/03/2014SE |
| K140370 | Disposable Pressure ManometerCAP · Traditional | 06/19/2014SE |
| K091272 | Besmed Jet Nebulizer Bottle SetCAF · Traditional | 11/10/2009SE |
| K031374 | Besmed Various Models of TENS, BE-550/BE-660GZJ · Traditional | 11/28/2003SE |
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Questions and answers
When was Triball Incentive Spirometer cleared by the FDA?
Triball Incentive Spirometer (K133873) received a 510(k) decision of Substantially Equivalent on April 4, 2014, 105 days after the submission was received.
What is the product code of K133873?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.