Comby EEG Caps— 510(k) K211315
Substantially EquivalentPamel D.O.O
FDA 510(k) clearance K211315 for Comby EEG Caps, Substantially Equivalent on 2021-11-09. Applicant: Pamel D.O.O. Device class: 2.
Clearance details
- Applicant
- Pamel D.O.O
- 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
- Zagreb, HR
Recent devices under product code GXY
view all- K262654 — Dexus Prosthetic System (MSL2, MSR2)
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- K261442 — Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array
- K261522 — BioWave BioWraps
- K253237 — Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
Data sourced from openFDA. This site is unofficial and independent of the FDA.