Emg Ac/Dc Suction Unit
FDA 510(k) K063448 · Emg Technology Co., Ltd.
510(k) numberK063448
Submission
- Device name
- Emg Ac/Dc Suction Unit
- Applicant
- Emg Technology Co., Ltd.
Shituen Chiu, Taichung, TW - Received
- November 15, 2006
- Decision date
- November 30, 2006
- 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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| 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 |
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Questions and answers
When was Emg Ac/Dc Suction Unit cleared by the FDA?
Emg Ac/Dc Suction Unit (K063448) received a 510(k) decision of Substantially Equivalent on November 30, 2006, 15 days after the submission was received.
What is the product code of K063448?
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.