FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AIRWAY, DUAL CHANNEL
K Number: K760488
·
Decision Sep 3, 1976
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
56
Applicant Total
33
Review Days
14
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Basic Information
- Device Name
- AIRWAY, DUAL CHANNEL
- K Number
- K760488
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5110
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Hudson Oxygen Therapy Sales Co.
- Date Received
- August 20, 1976
- Decision Date
- September 3, 1976
- Product Code
- CAE
- 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 |
|---|---|---|---|
| CAE | Airway, Oropharyngeal, Anesthesiology | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAE), ordered by most recent decision date.
LMA FAMILY OF AIRWAYS
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KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305
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KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205
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KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105
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CUFFED OROPHARYNGEAL AIRWAY (COPA)
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FDA Class 1
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RUSCH OPTOSAFE
FDA 510(k)
FDA Class 1
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Other Clearances by Hudson Oxygen Therapy Sales Co.
| K Number | Device Name | ||
|---|---|---|---|
| K902062 | PEEP VALVE | Sep 4, 1990 | Substantially Equivalent |
| K900783 | MDI ADAPTOR | Jul 18, 1990 | Substantially Equivalent |
| K900470 | IN-THE NEBULIZER | May 18, 1990 | Substantially Equivalent |
| K895589 | MANUAL RESUSCITATOR | Mar 30, 1990 | Substantially Equivalent |
| K896136 | INFANT C.P.A.P. MONITOR | Jan 9, 1990 | Substantially Equivalent |
| K895231 | CATALOG NO. 1755 1S0-NEB, A FILTERED NEBULIZER | Oct 27, 1989 | Substantially Equivalent |
| K895747 | VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR | Oct 27, 1989 | Substantially Equivalent |
| K890035 | BACTERIA FILTER | May 5, 1989 | Substantially Equivalent |
| K870895 | NO. 1552, VALVED VENTI-COMP | May 4, 1987 | Substantially Equivalent |
| K871157 | C.P.A.P. NASAL CANNULA | Apr 21, 1987 | Substantially Equivalent |