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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record DEN170072

ventilatory electrical impedance tomograph · timpel, inc. · decided 2018-12-20 (DENG)

FDA 510(k) database ↗

Devices

BrandModelCompanyProduct codesPrimary DI
ENLIGHT BELT - L – RIGHTAD-04021Timpel S/AQEB07898959841705
ENLIGHT BELT - XS – LEFTAD-04016Timpel S/AQEB07898959841651
ENLIGHT ELECTRODE ADDERE - SIZE SACE-00031Timpel S/AQEB07898966433269
ENLIGHT BELT - L – RIGHTACE-00028Timpel S/AQEB07898966433221
ENLIGHT ELECTRODE ADDERE - SIZE LACE-00033Timpel S/AQEB07898966433283
ENLIGHT ELECTRODE ADDERE - SIZE MACE-00032Timpel S/AQEB07898966433276
ENLIGHT BELT - S - RIGHTACE-00024Timpel S/AQEB07898966433184
ENLIGHT PATIENT REFERENCE CABLEDX-0TC03Timpel S/AQEB07898959841729
ENLIGHT BELT – XS – RIGHTAD-04015Timpel S/AQEB07898959841644
ENLIGHT BELT - M – LEFTACE-00027Timpel S/AQEB07898966433245
ENLIGHT BELT - XS – LEFTACE-00023Timpel S/AQEB07898966433177
ENLIGHT BELT – XS – RIGHTACE-00022Timpel S/AQEB07898966433160
ENLIGHT BELT - S – LEFTACE-00025Timpel S/AQEB07898966433191
ENLIGHT ELECTRODE ADDERE - SIZE XSACE-00030Timpel S/AQEB07898966433252
ENLIGHT BELT - M – LEFTAD-04020Timpel S/AQEB07898959841699
ENLIGHT BELT - S - RIGHTAD-04017Timpel S/AQEB07898959841668
ENLIGHT BELT - M – RIGHTACE-00026Timpel S/AQEB07898966433207
ENLIGHT BELT - L – LEFTACE-00029Timpel S/AQEB07898966433238
ENLIGHT 2100TPL-E2103-0Timpel S/AQEB07898966433146
ENLIGHT BELT - M – RIGHTAD-04019Timpel S/AQEB07898959841682
ENLIGHT PATIENT REFERENCE CABLEACE-00034Timpel S/AQEB07898966433290
ENLIGHT 1810TP-ENU00-0Timpel S/AQEB07898959841415
ENLIGHT BELT - L – LEFTAD-04022Timpel S/AQEB07898959841712
SHAPER No.2ACE-00035Timpel S/AQEB07898966433306
ENLIGHT BELT - S - LEFTAD-04018Timpel S/AQEB07898959841675