510(k) K851623

MODEL TRC-40 TELEMETRY RECIEVER MODULE by Eaton Medical Group — Product Code DXH

K851623 is an FDA 510(k) premarket notification submitted by Eaton Medical Group for the device "MODEL TRC-40 TELEMETRY RECIEVER MODULE". The FDA issued a decision of Substantially Equivalent on January 22, 1986. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920. Eaton Medical Group has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1986
Date Received
April 18, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Device Class
Class II
Regulation Number
870.2920
Review Panel
CV
Submission Type