510(k) K942567

MASS SPECTROMETRY MONITORING LINES AND CONNECTORS by Med-Plastics Intl., Inc. — Product Code CCK

K942567 is an FDA 510(k) premarket notification submitted by Med-Plastics Intl., Inc. for the device "MASS SPECTROMETRY MONITORING LINES AND CONNECTORS". The FDA issued a decision of Substantially Equivalent on June 10, 1994. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Med-Plastics Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1994
Date Received
May 31, 1994
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