FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OXYGEN SUPPLY TUBE, DISP., PLASTIC
K Number: K781231
·
Decision Sep 11, 1978
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
61
Applicant Total
2
Review Days
52
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Basic Information
- Device Name
- OXYGEN SUPPLY TUBE, DISP., PLASTIC
- K Number
- K781231
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5860
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Rtec
- Date Received
- July 21, 1978
- Decision Date
- September 11, 1978
- Product Code
- BYX
- 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 |
|---|---|---|---|
| BYX | Tubing, Pressure And Accessories | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
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Other Clearances by Rtec
| K Number | Device Name | ||
|---|---|---|---|
| K781232 | IPPB ASSEMBLY W/NEBULIZER | Sep 27, 1978 | Substantially Equivalent |