FDA 510(k)

The TANGO3 Water Storage Tank with Ozone Disinfection System has been assigned FDA 510(k) 093641

Microorganisms Killed by Single Cycle of Ozone

Microorganisms Killed by Single Cycle of Ozone*

Bacteria/organism

Maximum Bioburden

Cycle Time

Result

Acidovorax

11,000.000 CFU

30 minutes

None detected

Pseudomonas Aeruginosa. and Burkholderia Cepacia

18,000,000 CFU

30 minutes

None detected

Brevundimonas Diminuta

4,000,000 CFU

30 minutes

None detected

Mycobacterium Fortuitum

5,200,000 CFU

30 minutes

None detected

Fungi

Aspergillus Fumigatus **

1,150,000 CFU

30 minutes

None detected

Candida Tropicalis

44,000,000 CFU

30 minutes

None detected

Viruses

Poliovirus type 1

550 Log10TCID50/mL

30 minutes

None detected

Rotavirus

550 Log10TCID50/mL

30 minutes

None detected

Herpes Simplex Virus Type 1

750 Log10TCID50/mL

30 minutes

None detected

 

*Multiple tests were conducted for each organism.  The results in the table demonstrate the maximum bioburden in each test except for Aspergillus fumigatus.  All other organisms resulted in “None detected” in every test.

**Five (5) tests were conducted for this fungus.  Two of the tests did show a 30 minute cycle was not sufficient to completely eliminate the bioburden.  One of those had 1,200,000 CFU’s at the beginning of the test.  The other one had 810,000 CFU’s .  The bioburden caused the water color to be black to charcoal black, but appeared normal at the end of the 30 minute cycle.