510(k) K851466
K851466 is an FDA 510(k) premarket notification submitted by Dadsun Corp., Ltd. for the device "CARNATION - OXYGEN MASK". The FDA issued a decision of Substantially Equivalent on June 19, 1985. The device falls under product code BYG (Mask, Oxygen), a Class I device regulated under 21 CFR 868.5580. Dadsun Corp., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 19, 1985
- Date Received
- April 11, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mask, Oxygen
- Device Class
- Class I
- Regulation Number
- 868.5580
- Review Panel
- AN
- Submission Type