FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SILICONE RUGGER DISPOSABLE YOKE-CPAP
K Number: K834078
·
Decision Dec 27, 1983
Classifications
1
FEI Numbers
122
Registration Numbers
122
Same Product Code
18
Applicant Total
4
Review Days
29
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Basic Information
- Device Name
- SILICONE RUGGER DISPOSABLE YOKE-CPAP
- K Number
- K834078
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5100
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Vesta, Inc.
- Date Received
- November 28, 1983
- Decision Date
- December 27, 1983
- Product Code
- BTQ
- 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 |
|---|---|---|---|
| BTQ | Airway, Nasopharyngeal | FDA class 1 | Anesthesiology |
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