XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES— 510(k) K112426
Substantially EquivalentXian Friendship Medical Electronics Co., Ltd.
FDA 510(k) clearance K112426 for XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES, Substantially Equivalent on 2012-04-02. Applicant: Xian Friendship Medical Electronics Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Xian Friendship Medical Electronics Co., Ltd.
- Product code
- Code ETN
- Device class
- Class 2
- Regulation
- 21 CFR 874.1820
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Haidian Dis., Beijing, CN
Recent devices under product code ETN
view all- K253536 — Evala Nerve Stimulator (EPNR002)
- K251672 — NIM Essence EMG Endotracheal Tube (5 models)
- K242852 — ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)
- K233001 — Bioscope Neuromonitor Device
- K241917 — EARP Nerve Cuff Electrode
More clearances from Xian Friendship Medical Electronics Co., Ltd.
view allAdverse events under product code ETN
product code ETN- Death
- 7
- Injury
- 327
- Malfunction
- 2,776
- Total
- 3,110
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.