FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OXYGEN HOODS
K Number: K791861
·
Decision Oct 4, 1979
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
8
Applicant Total
2
Review Days
10
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Basic Information
- Device Name
- OXYGEN HOODS
- K Number
- K791861
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5700
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Ann Arbor Plastics, Inc.
- Date Received
- September 24, 1979
- Decision Date
- October 4, 1979
- 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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BURLEW INFANT HOOD
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SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION)
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DISPOSA-HOOD
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RT-HOOD
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Other Clearances by Ann Arbor Plastics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K802653 | MEDIUM SIZE OXYGEN HOOD #1547 | Nov 24, 1980 | Substantially Equivalent |