FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OXYGEN CANNULA EAR WRAP (STYLE B)
K Number: K863432
·
Decision Sep 18, 1986
Classifications
1
FEI Numbers
263
Registration Numbers
263
Same Product Code
41
Applicant Total
48
Review Days
14
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Basic Information
- Device Name
- OXYGEN CANNULA EAR WRAP (STYLE B)
- K Number
- K863432
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5340
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Salter Labs
- Date Received
- September 4, 1986
- Decision Date
- September 18, 1986
- 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
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| K051313 | BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER | Sep 15, 2005 | Substantially Equivalent |
| K040202 | SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM | Mar 4, 2005 | Substantially Equivalent |
| K014056 | SALTER LABS MODIFIED NEBUTECH NEBULIZER | Feb 1, 2002 | Substantially Equivalent |