510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY https://edrn.jpl.nasa.gov/resources/miscellaneous-resources/http-www-accessdata-fda-gov-cdrh_docs-reviews-1 https://edrn.jpl.nasa.gov/logo.png 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY URI: http://www.accessdata.fda.gov/cdrh_docs/reviews/K112603.pdf