510(k) K896731
K896731 is an FDA 510(k) premarket notification submitted by Unoplast A/S for the device "OXYGEN CATHETERS". The FDA issued a decision of Substantially Equivalent on March 30, 1990. The device falls under product code BZB (Catheter, Nasal, Oxygen), a Class I device regulated under 21 CFR 868.5350. Unoplast A/S has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 30, 1990
- Date Received
- November 30, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Nasal, Oxygen
- Device Class
- Class I
- Regulation Number
- 868.5350
- Review Panel
- AN
- Submission Type