FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OXYGEN CONNECTING TUBESET-RESPIRATORY
K Number: K832660
·
Decision Sep 26, 1983
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
61
Applicant Total
2
Review Days
49
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Basic Information
- Device Name
- OXYGEN CONNECTING TUBESET-RESPIRATORY
- K Number
- K832660
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5860
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- San Diego Plastics, Inc.
- Date Received
- August 8, 1983
- Decision Date
- September 26, 1983
- 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 |
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Other Clearances by San Diego Plastics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K830527 | N.E.W. NEB | Apr 12, 1983 | Substantially Equivalent |