FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NASAL CANNULA
K Number: K823506
·
Decision Dec 9, 1982
Classifications
1
FEI Numbers
263
Registration Numbers
263
Same Product Code
41
Applicant Total
7
Review Days
15
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Basic Information
- Device Name
- NASAL CANNULA
- K Number
- K823506
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5340
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Seven Harvest Intl. Import & Export
- Date Received
- November 24, 1982
- Decision Date
- December 9, 1982
- Product Code
- CAT
- 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 |
|---|---|---|---|
| CAT | Cannula, Nasal, Oxygen | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAT), ordered by most recent decision date.
NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI
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NASAL CANNULA
FDA 510(k)
FDA Class 1
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4 SURE TM NASAL OXYGEN CANNULA
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SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED
FDA 510(k)
FDA Class 1
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CANNULA NASAL OXYGEN
FDA 510(k)
FDA Class 1
·Anesthesiology
NASAL OXYGEN CANNULA, 81585, 81587 & 81589
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Seven Harvest Intl. Import & Export
| K Number | Device Name | ||
|---|---|---|---|
| K940793 | DOUBLE TRACH SWIVEL CONNECTOR | Jul 1, 1994 | Substantially Equivalent |
| K823141 | OXYGEN MASKS | Nov 29, 1982 | Substantially Equivalent |
| K823142 | OXYGEN TUBINGS | 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 |