Incoming generated [Feb 22 2016]

0202-EX-ST-2016 Correspondence

MC10 Inc.

2016-02-22ELS_173105

From: Stephen Lee

To: Behnam Ghaffari
Date: February 22, 2016

Subject: FCC File No. 0202-EX-ST-2016
----------------------------------------------------------------------------------------------------------------
Message:

Hi Mr. Ghaffari,

1) We are asking for 300 because this is a disposable device that is 1 time use. Fifty units are,
unfortunately, not adequate. When the clinician first applies the device, s/he has to ensure that it is
positioned properly to obtain physiological signal on the chest. Since body types and skin types are
different, the clinician is given several devices to check for optimal placement. If the initial placement is
not deemed adequate, the device is removed from the body and unused (since it is a 1 time use device
and has touched skin). Only 1 device will ultimately be used per patient but we are allotting several
devices per subject so that the strongest signal can be detected. All devices (those that are used on
patients, and those that were applied on skin but not used are returned to us for disposal).

2) This is not a market study. It is a technical feasibility study.

3) Yes we retrieve all devices.

Document Created: 2016-02-22 09:17:40
Document Modified: 2016-02-22 09:17:40

© 2026 FCC.report
This site is not affiliated with or endorsed by the FCC