LUXMATIC 12-15 ISC PORTABLE ELECTRIC BREAST PUMP

LUXMATIC 12-15 ISC PORTABLE ELECTRIC BREAST PUMP is an FDA 510(k)-cleared medical device (K971543) manufactured by Kaweco GmbH. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 17, 1997. Regulation: 8.