FDA 510(k)
FDA class 2
Substantially Equivalent
🇿🇦 South Africa
EMOX
K Number: K984081
·
Decision Mar 17, 1999
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
286
Applicant Total
2
Review Days
121
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Basic Information
- Device Name
- EMOX
- K Number
- K984081
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5440
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Emox 911 CC
- Date Received
- November 16, 1998
- Decision Date
- March 17, 1999
- Product Code
- CAW
- 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 |
|---|---|---|---|
| CAW | Generator, Oxygen, Portable | FDA class 2 | Anesthesiology |
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Other Clearances by Emox 911 CC
| K Number | Device Name | ||
|---|---|---|---|
| K984082 | BURN-AID HYDROGEL, BURN-AID BURN DRESSING, BURN-AID BURN BLANKET | Jan 28, 1999 | Substantially Equivalent |