Hudson RCI Voldyne Volumetric Exerciser
FDA 510(k) K182847 · Teleflexmedical, Inc.
510(k) numberK182847
Submission
- Device name
- Hudson RCI Voldyne Volumetric Exerciser
- Applicant
- Teleflexmedical, Inc.
Morrisville, NC, US - Received
- October 9, 2018
- Decision date
- July 1, 2019
- 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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Questions and answers
When was Hudson RCI Voldyne Volumetric Exerciser cleared by the FDA?
Hudson RCI Voldyne Volumetric Exerciser (K182847) received a 510(k) decision of Substantially Equivalent on July 1, 2019, 265 days after the submission was received.
What is the product code of K182847?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.