510(k) K812560

MDM ARTERIAL BLOOD GAS SYRINGE by Martell Medical Products, Inc. — Product Code FMF

K812560 is an FDA 510(k) premarket notification submitted by Martell Medical Products, Inc. for the device "MDM ARTERIAL BLOOD GAS SYRINGE". The FDA issued a decision of Substantially Equivalent on October 9, 1981. 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
October 9, 1981
Date Received
September 8, 1981
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