PROGRAMMABLE SPINAL CORAL STIM. SYSTEM— 510(k) K810182
Substantially EquivalentElectronic Diagnostics, Inc.
FDA 510(k) clearance K810182 for PROGRAMMABLE SPINAL CORAL STIM. SYSTEM, Substantially Equivalent on 1981-04-03. Applicant: Electronic Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Electronic Diagnostics, Inc.
- Product code
- Code GZB
- Device class
- Class 2
- Regulation
- 21 CFR 882.5880
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code GZB
view all- K233801 — Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation
- K221376 — Nalu Neurostimulation System
- K203547 — Nalu Neurostimulation System
- K202274 — Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits
- K201618 — Nalu Neurostimulation SCS system
Adverse events under product code GZB
product code GZB- Death
- 4
- Injury
- 1,879
- Other
- 2
- Total
- 1,885
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.