Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)— 510(k) K253237
Substantially EquivalentElde Medikal Sanayi ve Ticaret Anonim Sirketi
FDA 510(k) clearance K253237 for Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode), Substantially Equivalent on 2026-05-08. Applicant: Elde Medikal Sanayi ve Ticaret Anonim Sirketi. Device class: 2.
Clearance details
- Applicant
- Elde Medikal Sanayi ve Ticaret Anonim Sirketi
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Umraniye/Istanbul, TR
Recent devices under product code GXY
view all- K262654 — Dexus Prosthetic System (MSL2, MSR2)
- K260578 — Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)
- K261442 — Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array
- K261522 — BioWave BioWraps
- K254183 — MR Conditional Cup Electrodes
Data sourced from openFDA. This site is unofficial and independent of the FDA.