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James salmon

05/26/22 10:16 AM

#30739 RE: MouthBreather #30738

Let’s not forget they brought in a company with 100% track record of getting 510k’s approved.
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ZetaReticuli

05/26/22 10:21 AM

#30742 RE: MouthBreather #30738

The "orders" are for third party cpap machines. They can't sell the DeltaWave until the 510k is cleared by the FDA. The company is currently valued at over $50 million dollars which is ABSURD when the same third party cpap machines are a dime a dozen all over the internet.
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ZetaReticuli

05/26/22 10:27 AM

#30745 RE: MouthBreather #30738

They failed two cytotoxicity tests and the communication regarding disclosure didn't occur until a year after the test failed and it also recently failed the retest: