FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BURLEW INFANT HOOD
K Number: K962182
·
Decision Jul 15, 1996
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
8
Applicant Total
16
Review Days
39
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Basic Information
- Device Name
- BURLEW INFANT HOOD
- K Number
- K962182
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5700
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Promedic, Inc.
- Date Received
- June 6, 1996
- Decision Date
- July 15, 1996
- Product Code
- FOG
- 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 |
|---|---|---|---|
| FOG | Hood, Oxygen, Infant | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FOG), ordered by most recent decision date.
OLYMPUS NA-10J-1 ASPIRATION NEEDLE
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SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION)
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FDA Class 1
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ENDO-GUARD
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DISPOSA-HOOD
FDA 510(k)
FDA Class 1
·Anesthesiology
OXYGEN HOODS
FDA 510(k)
FDA Class 1
·Anesthesiology
RT-HOOD
FDA 510(k)
FDA Class 1
·Anesthesiology
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