510(k) K832725
K832725 is an FDA 510(k) premarket notification submitted by Airlife, Inc. for the device "DUAL DIAL VENTURI STYLE MASK". The FDA issued a decision of Substantially Equivalent on September 20, 1983. The device falls under product code BYF (Mask, Oxygen, Low Concentration, Venturi), a Class I device regulated under 21 CFR 868.5600. Airlife, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 1983
- Date Received
- August 12, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mask, Oxygen, Low Concentration, Venturi
- Device Class
- Class I
- Regulation Number
- 868.5600
- Review Panel
- AN
- Submission Type