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

Clearance record K162199

Cascade IOMAX Intraoperative Monitor · Cadwell Industries, Inc. · decided 2017-03-02 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Cascade IOMAX199291-200CADWELL INDUSTRIES, INC.DQA ETN GWE GWF GWJ GWQ GZO IKN JXE OLT00840067102831
Disposable Goggle Foam197278-000CADWELL INDUSTRIES, INC.DQA ETN GWE GWF GWJ GWQ GZO IKN JXE OLT00840067102244
Cascade IOMAX199306-200CADWELL INDUSTRIES, INC.DQA ETN GWE GWF GWJ GWQ GZO IKN JXE OLT00840067103616
IOMAX Adapter362072-000CADWELL INDUSTRIES, INC.DQA ETN GWE GWF GWJ GWQ GZO IKN JXE OLT00840067102688
IOMAX Extender Pod362071-000CADWELL INDUSTRIES, INC.DQA ETN GWE GWF GWJ GWQ GZO IKN JXE OLT00840067102671
Cascade IOMAX Intraoperative Monitor190299-200CADWELL INDUSTRIES, INC.DQA ETN GWE GWF GWJ GWQ GZO IKN JXE OLT00840067102220
Cascade IOMAX Intraoperative Monitor190291-200CADWELL INDUSTRIES, INC.DQA ETN GWE GWF GWJ GWQ GZO IKN JXE OLT00840067100639
Cascade IOMAX362061-000CADWELL INDUSTRIES, INC.DQA ETN GWE GWF GWJ GWQ GZO IKN JXE OLT00840067102862
IOMAX Extender Pod362068-000CADWELL INDUSTRIES, INC.DQA ETN GWE GWF GWJ GWQ GZO IKN JXE OLT00840067102657
Cascade IOMAX Intraoperative Monitor190309-200CADWELL INDUSTRIES, INC.DQA ETN GWE GWF GWJ GWQ GZO IKN JXE OLT00840067102763
Cascade IOMAX199289-200CADWELL INDUSTRIES, INC.DQA ETN GWE GWF GWJ GWQ GZO IKN JXE OLT00840067102053
Cascade IOMAX Intraoperative Monitor190296-200CADWELL INDUSTRIES, INC.DQA ETN GWE GWF GWJ GWQ GZO IKN JXE OLT00840067100653
Cascade IOMAX Intraoperative Monitor199305-200CADWELL INDUSTRIES, INC.DQA ETN GWE GWF GWJ GWQ GZO IKN JXE OLT00840067102718
Cascade IOMAX Intraoperative Monitor190295-200CADWELL INDUSTRIES, INC.DQA ETN GWE GWF GWJ GWQ GZO IKN JXE OLT00840067100646
IOMAX Adapter362069-000CADWELL INDUSTRIES, INC.DQA ETN GWE GWF GWJ GWQ GZO IKN JXE OLT00840067102664