FDA 510(k) Premarket Notification K891148: MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM

Submission Details & Decision

Normalized public record details for 510(k) notification K891148.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K891148

Applicant / Sponsor

Del Mar Avionics

Device Name

MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM

Product Code

DSI

Decision Date

1989-05-11

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Traditional

Third Party Flag

Date Received

1989-03-03

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