FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESPIRONICS PR VALVE
K Number: K833327
·
Decision Nov 28, 1983
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
38
Applicant Total
172
Review Days
62
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Basic Information
- Device Name
- RESPIRONICS PR VALVE
- K Number
- K833327
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5750
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Respironics, Inc.
- Date Received
- September 27, 1983
- Decision Date
- November 28, 1983
- Product Code
- BSK
- 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 |
|---|---|---|---|
| BSK | Cuff, Tracheal Tube, Inflatable | FDA class 2 | Anesthesiology |
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Cuffix
FDA 510(k)
FDA Class 2
·Anesthesiology
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