FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HI FLOW 50
K Number: K882328
·
Decision Jun 28, 1988
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
54
Applicant Total
4
Review Days
22
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Basic Information
- Device Name
- HI FLOW 50
- K Number
- K882328
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5655
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Minnesota Valley Engineering, Inc.
- Date Received
- June 6, 1988
- Decision Date
- June 28, 1988
- Product Code
- BYJ
- 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 |
|---|---|---|---|
| BYJ | Unit, Liquid-Oxygen, Portable | FDA class 2 | Anesthesiology |
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