510(k) K894457
K894457 is an FDA 510(k) premarket notification submitted by Dadsun Corp., Ltd. for the device "CARNATION TRACHEOSTOMY MASKS". The FDA issued a decision of Substantially Equivalent on October 13, 1989. The device falls under product code BYF (Mask, Oxygen, Low Concentration, Venturi), a Class I device regulated under 21 CFR 868.5600. Dadsun Corp., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 1989
- Date Received
- July 18, 1989
- 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