Multiple, Model #17
FDA 510(k) K820823 · Midmark Corp.
510(k) numberK820823
Submission
- Device name
- Multiple, Model #17
- Applicant
- Midmark Corp.
Mchenry, IL, US - Received
- March 24, 1982
- Decision date
- April 21, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LGX – Table, Examination, Medical, Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4960
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code LGX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K945163 | EchocardiographyLGX · Traditional | Tri W-G, Inc. | 02/17/1995SE |
| K894144 | Power Examination Table Model # 405LGX · Traditional | Midmark Corp. | 08/28/1989SE |
| K894134 | Power Examination Table Model # 411LGX · Traditional | Midmark Corp. | 08/28/1989SE |
| K883680 | Medalist Examination TableLGX · Traditional | Hamilton Industries, Inc. | 10/04/1988SE |
| K882010 | Power Examination TableLGX · Traditional | Enochs Mfg., Inc. | 07/13/1988SE |
| K864072 | Adec 1005-C ChairLGX · Traditional | Cherne Industries, Inc. | 11/07/1986SE |
| K860519 | Reliance Model 200 Podiatry ChairLGX · Traditional | F. & F. Koenigkramer | 02/19/1986SE |
| K845023 | Storz Plastic Surgery & Examination Lounge 7000LGX · Traditional | Storz Instrument Co. | 01/28/1985SE |
| K830294 | Medical Exam TableLGX · Traditional | Coe Laboratories, Inc. | 01/11/1984SE |
| K832768 | S & W SW52E W/Power Back LiftLGX · Traditional | S & W Enterprises, Inc. | 09/20/1983SE |
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| K161909 | IQvitals ZoneMWI · Traditional | 11/17/2016SE |
| K122643 | Vantage Model V5000, V5100, V5000C, V5100CMUH · Traditional | 01/07/2013SE |
| K120239 | ElevanceEIA · Special | 08/24/2012SE |
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Questions and answers
When was Multiple, Model #17 cleared by the FDA?
Multiple, Model #17 (K820823) received a 510(k) decision of Substantially Equivalent on April 21, 1982, 28 days after the submission was received.
What is the product code of K820823?
The FDA product code is LGX – Table, Examination, Medical, Powered, a Class I (low risk) device regulated under 21 CFR 878.4960.