FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DUAL DIAL VENTURI STYLE MASK
K Number: K832725
·
Decision Sep 20, 1983
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
18
Applicant Total
76
Review Days
39
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Basic Information
- Device Name
- DUAL DIAL VENTURI STYLE MASK
- K Number
- K832725
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5600
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Airlife, Inc.
- Date Received
- August 12, 1983
- Decision Date
- September 20, 1983
- Product Code
- BYF
- 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 |
|---|---|---|---|
| BYF | Mask, Oxygen, Low Concentration, Venturi | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
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OXY-DIAL
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Other Clearances by Airlife, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K834573 | AQUA TRAP | Mar 5, 1984 | Substantially Equivalent |
| K834570 | VOLUME VENTILATOR CIRCUIT W/WATER TRAP | Mar 5, 1984 | Substantially Equivalent |
| K834077 | SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN | Dec 12, 1983 | Substantially Equivalent |
| K833196 | VOLUME VENTILATOR CIRCUIT-NEBULIZER | Nov 3, 1983 | Substantially Equivalent |
| K833197 | TRACH SWIVE/CONNECTOR | Oct 28, 1983 | Substantially Equivalent |
| K831246 | WHISTLER IN-LINE PRESSURE RELEASE VALVE | Jul 26, 1983 | Substantially Equivalent |
| K830895 | SINGLE USE NEBULIZER, ADJUST. AIR- | Apr 28, 1983 | Substantially Equivalent |
| K830896 | HUMIDIFIER, WITH OR WITHOUT ADAPTER | Apr 18, 1983 | Substantially Equivalent |
| K821129 | AIRLIFE NEBULIZER HEATER | May 18, 1982 | Substantially Equivalent |
| K821128 | DISPOSABLE THERMOPLASTIC RUBBER MOUTH | May 13, 1982 | Substantially Equivalent |