Sec.  95.1109   Equipment authorization requirement.

   (a) Wireless medical telemetry devices operating under this part must be
   authorized under the certification procedure prior to marketing or use in
   accordance with the provisions of part 2, subpart J of this chapter.

   (b) Each device shall be labeled with the following statement:

   Operation of this equipment requires the prior coordination with a frequency
   coordinator  designated  by the FCC for the Wireless Medical Telemetry
   Service.