FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ROYAL
K Number: K800866
·
Decision May 28, 1980
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
54
Applicant Total
3
Review Days
42
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Basic Information
- Device Name
- ROYAL
- K Number
- K800866
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5330
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Trident Dental, Inc.
- Date Received
- April 16, 1980
- Decision Date
- May 28, 1980
- Product Code
- BZR
- 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 |
|---|---|---|---|
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | FDA class 2 | Anesthesiology |
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