510(k) K910970

MARKSMAN ARTERIAL BLOOD GAS SYRINGE by Martech Medical Products, Inc. — Product Code JKA

K910970 is an FDA 510(k) premarket notification submitted by Martech Medical Products, Inc. for the device "MARKSMAN ARTERIAL BLOOD GAS SYRINGE". The FDA issued a decision of Substantially Equivalent on October 15, 1991. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Martech Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1991
Date Received
March 7, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type