(
Med Lett Drugs Ther 2007; 49:55) The second sentence in the article ("The FDA does not require proof of effectiveness for approval of devices with minimal potential for harm, such as this one.") should have been omitted. It would apply to a Class I device, but the FDA has classified
Resperate as a Class II device.
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Information about the article:
Title: Correction: Resperate for Hypertension
Publication: The Medical Letter on Drugs and Therapeutics
Issue #: 1268
Article Code: 1268c
Date: August 27, 2007
Volume: 49
Page: 72
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