510(k) K900551

MATRX DISPOSABLE NON-INVASIVE GELLED PACING ELEC. by Matrix Medica, Inc. — Product Code DRS

K900551 is an FDA 510(k) premarket notification submitted by Matrix Medica, Inc. for the device "MATRX DISPOSABLE NON-INVASIVE GELLED PACING ELEC.". The FDA issued a decision of Substantially Equivalent on May 9, 1990. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850. Matrix Medica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1990
Date Received
February 6, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Blood-Pressure, Extravascular
Device Class
Class II
Regulation Number
870.2850
Review Panel
CV
Submission Type