Review tally, page-94

FDA RegisteredTo be clear, all medical devices sold in the USA must be registered with the FDA, or "FDA Registered." So, even a Class I medical device must be FDA Registered. If a device is only FDA Registered, the manufacturer cannot claim that it's Approved or Cleared. Why? Because the FDA hasn't actually determined whether it's fit for purpose or not, only that it's a low-risk product.Class I, FDA Registered devices won't have an FDA label.FDA ApprovedSome devices, such as Class III devices, need FDA Approval before coming to market. To secure FDA Approval, a manufacturer must show that the device is effective and safe for use.The manufacturer must have sufficient evidence available to support their claim

PMF spreads BS yet remains uncensored!
Once again you are wrong!!!! P… O..!