510(k) K822760

ARTERIAL LINE KIT by Martell Medical Products, Inc. — Product Code FMF

K822760 is an FDA 510(k) premarket notification submitted by Martell Medical Products, Inc. for the device "ARTERIAL LINE KIT". The FDA issued a decision of Substantially Equivalent on September 28, 1982. 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
September 28, 1982
Date Received
September 14, 1982
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