FDA 510(k) Premarket Notification K820986: EKG MONITORS, VARIOUS MODELS

Submission Details & Decision

Normalized public record details for 510(k) notification K820986.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K820986

Applicant / Sponsor

Dart Medical Equipment

Device Name

EKG MONITORS, VARIOUS MODELS

Product Code

DXH

Decision Date

1982-04-29

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Traditional

Third Party Flag

Date Received

1982-04-06

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