Impact, Model E-12
FDA 510(k) K820330 · Impact Instrumentation, Inc.
510(k) numberK820330
Submission
- Device name
- Impact, Model E-12
- Applicant
- Impact Instrumentation, Inc.
Mchenry, IL, US - Received
- February 8, 1982
- Decision date
- February 23, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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More from Taiwan Biomaterial Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K133196 | Impact Model 323 AspiratorJCX · Traditional | 03/10/2014SE |
| K111473 | Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorCBK · Traditional | 02/16/2012SE |
| K103318 | Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorCBK · Traditional | 04/07/2011SE |
| K091238 | UNI-VENT-731 Series Ventilators, Model 731EMV+CBK · Traditional | 08/13/2009SE |
| K071526 | Uni-Vent 731 Series Ventilators, Model 731, 731EMVCBK · Traditional | 12/10/2008SE |
| K051476 | Uni-Vent Model 73XBTL · Traditional | 10/28/2005SE |
| K032386 | Uni-Vent Model 730AEV (Automatic Emergency Ventilator)BTL · Traditional | 03/26/2004SE |
| K022062 | Impact, Universal Single-Limb, Ventilator Circuit, Model 820-0099-00MOD · Abbreviated | 05/06/2003SE |
| K951423 | Aspirator, Continuous & Programmable IntermittentBTA · Traditional | 04/18/1995SE |
| K941096 | Electric Vacum PumpBTA · Traditional | 01/05/1995SE |
Questions and answers
When was Impact, Model E-12 cleared by the FDA?
Impact, Model E-12 (K820330) received a 510(k) decision of Substantially Equivalent on February 23, 1982, 15 days after the submission was received.
What is the product code of K820330?
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.