FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE
K Number: K123400
·
Decision May 16, 2013
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
107
Applicant Total
12
Review Days
192
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Basic Information
- Device Name
- AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE
- K Number
- K123400
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5690
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Trudell Medical Intl.
- Date Received
- November 5, 2012
- Decision Date
- May 16, 2013
- 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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