FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OXYGEN CATHETER
K Number: K800506
·
Decision Mar 25, 1980
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
7
Applicant Total
9
Review Days
21
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Basic Information
- Device Name
- OXYGEN CATHETER
- K Number
- K800506
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5350
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Medi-Craft , Ltd.
- Date Received
- March 4, 1980
- Decision Date
- March 25, 1980
- Product Code
- BZB
- 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 |
|---|---|---|---|
| BZB | Catheter, Nasal, Oxygen | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZB), ordered by most recent decision date.
OXYGEN CATHETERS
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DEMAND OXYGEN CONTROLLER
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OXYGEN CATHETERS
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CONPHAR OXYGEN CATHETER-STERILE
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Other Clearances by Medi-Craft , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K861949 | SUCTION CATHETER KIT | Oct 22, 1986 | Substantially Equivalent |
| K800508 | STOMACH TUBES | Apr 8, 1980 | Substantially Equivalent |
| K800510 | RECTAL & HARRIS FLUSH TUBES | Apr 8, 1980 | Substantially Equivalent |
| K800505 | URETHRAL CATHETER | Apr 8, 1980 | Substantially Equivalent |
| K800507 | FEEDING TUBES | Apr 8, 1980 | Substantially Equivalent |
| K800509 | CONNECTING TUBES | Mar 25, 1980 | Substantially Equivalent |
| K800503 | SUCTION CATHETER | Mar 18, 1980 | Substantially Equivalent |
| K800504 | OXYGEN CONNECTING TUBES | Mar 18, 1980 | Substantially Equivalent |