510(k) K890058
K890058 is an FDA 510(k) premarket notification submitted by Vascular Technology Incorporated for the device "VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM". The FDA issued a decision of Substantially Equivalent on November 21, 1989. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Vascular Technology Incorporated has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 1989
- Date Received
- January 6, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Oxygen, Gaseous-Phase
- Device Class
- Class II
- Regulation Number
- 868.1720
- Review Panel
- AN
- Submission Type