AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015— 510(k) K093622
Substantially EquivalentEncision, Inc.
FDA 510(k) clearance K093622 for AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015, Substantially Equivalent on 2010-08-20. Applicant: Encision, Inc.. Device class: 2.
Clearance details
- Applicant
- Encision, Inc.
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boulder, CO, US
Recent devices under product code GEI
view allMore clearances from Encision, Inc.
view all- K201018 — Encision AEM enTouch 2X Scissor
- K140006 — ENDOSHIELD BURN PROTECTION SYSTEM
- K131949 — AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES
- K122383 — EM3 AEM MONITOR AEM CONNECTORS
- K122580 — AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES MODEL ES077X SERIES
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.