FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDURANCE R3000
K Number: K942384
·
Decision Dec 19, 1994
Classifications
1
FEI Numbers
187
Registration Numbers
188
Same Product Code
503
Applicant Total
1
Review Days
214
Basic Information
- Device Name
- ENDURANCE R3000
- K Number
- K942384
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- ESSENTIAL MEDICAL SUPPLY, INC.
- Date Received
- May 19, 1994
- Decision Date
- December 19, 1994
- Product Code
- CAF
- 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 |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | FDA class 2 | Anesthesiology |
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