510(k) K890058

VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM by Vascular Technology Incorporated — Product Code CCL

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