FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INSPIROMETER
K Number: K833012
·
Decision Nov 8, 1983
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
107
Applicant Total
4
Review Days
63
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Basic Information
- Device Name
- INSPIROMETER
- K Number
- K833012
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5690
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Kinetix
- Date Received
- September 6, 1983
- Decision Date
- November 8, 1983
- 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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