FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEDIUM SIZE OXYGEN HOOD #1547
K Number: K802653
·
Decision Nov 24, 1980
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
10
Applicant Total
2
Review Days
31
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Basic Information
- Device Name
- MEDIUM SIZE OXYGEN HOOD #1547
- K Number
- K802653
- 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
- October 24, 1980
- Decision Date
- November 24, 1980
- Product Code
- BYL
- 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 |
|---|---|---|---|
| BYL | Tent, Oxygen | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYL), ordered by most recent decision date.
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KEYSTONE OXYGEN TENT
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Other Clearances by Ann Arbor Plastics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K791861 | OXYGEN HOODS | Oct 4, 1979 | Substantially Equivalent |