FDA 510(k) Premarket Notification K071802: TESLA GUARD, MODEL EFT G04

Submission Details & Decision

Normalized public record details for 510(k) notification K071802.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K071802

Applicant / Sponsor

Mammendorfer Institut Fur Physik Und Medizin GmbH

Device Name

TESLA GUARD, MODEL EFT G04

Product Code

MWI

Decision Date

2007-11-09

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Traditional

Third Party Flag

Date Received

2007-07-02

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