510(k) K841810

MARK5 ARTERIAL BLOOD GAS KIT by Martell Medical Products, Inc. — Product Code FMF

K841810 is an FDA 510(k) premarket notification submitted by Martell Medical Products, Inc. for the device "MARK5 ARTERIAL BLOOD GAS KIT". The FDA issued a decision of Substantially Equivalent on July 6, 1984. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Martell Medical Products, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1984
Date Received
May 1, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type