FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OXYGEN TUBINGS
K Number: K823142
·
Decision Nov 29, 1982
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
61
Applicant Total
7
Review Days
35
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Basic Information
- Device Name
- OXYGEN TUBINGS
- K Number
- K823142
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5860
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Seven Harvest Intl. Import & Export
- Date Received
- October 25, 1982
- Decision Date
- November 29, 1982
- 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 Seven Harvest Intl. Import & Export
| K Number | Device Name | ||
|---|---|---|---|
| K940793 | DOUBLE TRACH SWIVEL CONNECTOR | Jul 1, 1994 | Substantially Equivalent |
| K823506 | NASAL CANNULA | Dec 9, 1982 | Substantially Equivalent |
| K823141 | OXYGEN MASKS | Nov 29, 1982 | Substantially Equivalent |
| K823143 | BUBBLE HUMIDIFIERS | Nov 29, 1982 | Substantially Equivalent |
| K820709 | AIRWAYS | Jun 25, 1982 | Substantially Equivalent |
| K813074 | CONNECTORS & ADAPTERS | Dec 31, 1981 | Substantially Equivalent |