510(k) K910453

TOPS NEEDLE TIP PROBE & PVC TIP PROBE by Baxter Healthcare Corp — Product Code CCE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1991
Date Received
February 1, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
Device Class
Class II
Regulation Number
868.1200
Review Panel
AN
Submission Type