XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES

Stimulator, Nerve

XIAN FRIENDSHIP MEDICAL ELECTRONICS CO., LTD.

The following data is part of a premarket notification filed by Xian Friendship Medical Electronics Co., Ltd. with the FDA for Xian Friendship Disposable Nerve Stimulator Probes.

Pre-market Notification Details

• Device ID: K112426
• 510k Number: K112426
• Device Name: XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES
• Classification: Stimulator, Nerve
• Applicant: XIAN FRIENDSHIP MEDICAL ELECTRONICS CO., LTD. JIANXIANG YUAN #209 BEI SI HU ZHONG RD Haidian Dis., Beijing, CN 100083
• Contact: Chu Xiaoan
• Correspondent: Chu Xiaoan; XIAN FRIENDSHIP MEDICAL ELECTRONICS CO., LTD. JIANXIANG YUAN #209 BEI SI HU ZHONG RD Haidian Dis., Beijing, CN 100083
• Product Code: ETN
• CFR Regulation Number: 874.1820 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-08-23
• Decision Date: 2012-04-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
26955739000143	K112426	000
00840067101742	K112426	000
00840067101735	K112426	000
10840067100797	K112426	000
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26955739000389	K112426	000
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26955739000341	K112426	000
26955739000334	K112426	000
26955739000228	K112426	000
26955739000211	K112426	000
26955739000204	K112426	000
26955739000198	K112426	000
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26955739000327	K112426	000
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10840067101862	K112426	000
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26955739030157	K112426	000
26955739030140	K112426	000
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26955739030195	K112426	000
26955739030188	K112426	000
26955739030072	K112426	000
26955739030065	K112426	000
26955739013549	K112426	000
26955739013532	K112426	000
26955739013525	K112426	000
18657300002204	K112426	000
28657300002201	K112426	000
00840067102480	K112426	000
00840067101902	K112426	000
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26955739013556	K112426	000
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26955739013587	K112426	000
26955739013570	K112426	000
86573000022001	K112426	000