510(k) K914576

KELLER CARDIAC MONITOR MEDIL KMS870 by Keller Medical Specialties Products, Inc. — Product Code DRT

K914576 is an FDA 510(k) premarket notification submitted by Keller Medical Specialties Products, Inc. for the device "KELLER CARDIAC MONITOR MEDIL KMS870". The FDA issued a decision of Substantially Equivalent on December 30, 1991. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Keller Medical Specialties Products, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1991
Date Received
October 15, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type