Emg Suction Unit
FDA 510(k) K112421 · Emg Technology Co., Ltd.
510(k) numberK112421
Submission
- Device name
- Emg Suction Unit
- Applicant
- Emg Technology Co., Ltd.
Taichung, TW - Received
- August 23, 2011
- Decision date
- September 1, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
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| K190105 | ZOOM Aspiration PumpJCX · Special | Taiwan Biomaterial Co., Ltd. | 02/21/2019SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K072634 | Emg Triton -Comp,Model NCA01-XXX SeriesBTI · Traditional | 11/19/2008SE |
| K063448 | Emg Ac/Dc Suction UnitJCX · Traditional | 11/30/2006SE |
| K062888 | Middle Wheel Drive Power Chair, CWD01ITI · Traditional | 10/24/2006SE |
| K052438 | Emg Handle Nebulizer NB02 SeriesCAF · Abbreviated | 01/31/2006SE |
| K043520 | Emg CTA01-XXX Series Puro Oxygen ConcentratorCAW · Abbreviated | 10/21/2005SE |
| K043238 | Compressor Nebulizer, Model Emg NBA02-XXX SeriesCAF · Abbreviated | 07/06/2005SE |
| K042349 | Emg Model SUA01 Suction UnitJCX · Abbreviated | 12/16/2004SE |
| K033206 | Epw Foldable Power Wheelchair, EPW-03ITI · Traditional | 12/18/2003SE |
| K033204 | Esg 4-WHEEL Scooter, ESG-03INI · Traditional | 11/12/2003SE |
| K023148 | Epw Powered Wheelchair, GP-201ITI · Traditional | 01/24/2003SE |
Questions and answers
When was Emg Suction Unit cleared by the FDA?
Emg Suction Unit (K112421) received a 510(k) decision of Substantially Equivalent on September 1, 2011, 9 days after the submission was received.
What is the product code of K112421?
The FDA product code is JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 878.4780.