Hudson RCI Voldyne Volumetric Exerciser— 510(k) K182847
Substantially EquivalentTeleflexmedical, Inc.
FDA 510(k) clearance K182847 for Hudson RCI Voldyne Volumetric Exerciser, Substantially Equivalent on 2019-07-01. Applicant: Teleflexmedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Teleflexmedical, Inc.
- Product code
- Code BWF
- Device class
- Class 2
- Regulation
- 21 CFR 868.5690
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morrisville, NC, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.