510(k) K852625
K852625 is an FDA 510(k) premarket notification submitted by Ashai Co. , Ltd. for the device "OXY-TUBE". The FDA issued a decision of Substantially Equivalent on September 18, 1985. The device falls under product code CAT (Cannula, Nasal, Oxygen), a Class I device regulated under 21 CFR 868.5340. Ashai Co. , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 1985
- Date Received
- June 20, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cannula, Nasal, Oxygen
- Device Class
- Class I
- Regulation Number
- 868.5340
- Review Panel
- AN
- Submission Type