FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HOME-AWAY SYSTEM
K Number: K004047
·
Decision Dec 18, 2001
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
286
Applicant Total
2
Review Days
354
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Basic Information
- Device Name
- HOME-AWAY SYSTEM
- K Number
- K004047
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5440
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- In-X Corp.
- Date Received
- December 29, 2000
- Decision Date
- December 18, 2001
- 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 In-X Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K984570 | MINOLTA PULSOX-3/MINOLTA PULSOX-3I | Aug 30, 2000 | Substantially Equivalent |