GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03— 510(k) K013731
Substantially EquivalentGimmi GmbH
FDA 510(k) clearance K013731 for GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03, Substantially Equivalent on 2001-11-27. Applicant: Gimmi GmbH. Device class: 2.
Clearance details
- Applicant
- Gimmi GmbH
- Product code
- Code EOQ
- Device class
- Class 2
- Regulation
- 21 CFR 874.4680
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Amsterdam, Nh, NL
Recent devices under product code EOQ
view allMore clearances from Gimmi GmbH
view all- K261179 — AlphaTriPart - Monopolar MIC Instruments
- K092421 — ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC
- K093125 — ALPHAXENON LIGHT 180 W AND 300 W
- K081640 — GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS
- K012869 — GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25
Adverse events under product code EOQ
product code EOQ- Death
- 135
- Injury
- 2,863
- Malfunction
- 21,662
- Total
- 24,660
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.