Hudson RCI Triflo II Incentive Deep Breathing Exerciser— 510(k) K220565
Substantially EquivalentMedline Industries, Inc.
FDA 510(k) clearance K220565 for Hudson RCI Triflo II Incentive Deep Breathing Exerciser, Substantially Equivalent on 2022-10-25. Applicant: Medline Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Medline Industries, 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
- Northfield, IL, US
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