510(k) K930559

VITALMAX 800-C by Pace Tech, Inc. — Product Code CCK

K930559 is an FDA 510(k) premarket notification submitted by Pace Tech, Inc. for the device "VITALMAX 800-C". The FDA issued a decision of Substantially Equivalent on September 3, 1993. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Pace Tech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 1993
Date Received
February 3, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type