FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Hudson RCI Triflo II Incentive Deep Breathing Exerciser
K Number: K220565
·
Decision Oct 25, 2022
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
107
Applicant Total
238
Review Days
239
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Basic Information
- Device Name
- Hudson RCI Triflo II Incentive Deep Breathing Exerciser
- K Number
- K220565
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5690
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medline Industries, Inc.
- Date Received
- February 28, 2022
- Decision Date
- October 25, 2022
- Product Code
- BWF
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BWF | Spirometer, Therapeutic (Incentive) | FDA class 2 | Anesthesiology |
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