SMR Paragon Chair Table

FDA 510(k) K811623 · Smr

Substantially Equivalent

510(k) numberK811623

Submission

Device name
SMR Paragon Chair Table
Applicant
Smr
Mchenry, IL, US
Received
June 9, 1981
Decision date
July 2, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

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

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K945163EchocardiographyLGX · Traditional Tri W-G, Inc.02/17/1995SE
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K894134Power Examination Table Model # 411LGX · Traditional Midmark Corp.08/28/1989SE
K883680Medalist Examination TableLGX · Traditional Hamilton Industries, Inc.10/04/1988SE
K882010Power Examination TableLGX · Traditional Enochs Mfg., Inc.07/13/1988SE
K864072Adec 1005-C ChairLGX · Traditional Cherne Industries, Inc.11/07/1986SE
K860519Reliance Model 200 Podiatry ChairLGX · Traditional F. & F. Koenigkramer02/19/1986SE
K845023Storz Plastic Surgery & Examination Lounge 7000LGX · Traditional Storz Instrument Co.01/28/1985SE
K830294Medical Exam TableLGX · Traditional Coe Laboratories, Inc.01/11/1984SE
K832768S & W SW52E W/Power Back LiftLGX · Traditional S & W Enterprises, Inc.09/20/1983SE

More from S & W Enterprises, Inc.

510(k)DeviceDecision
K801767Dimension I Refraction SystemHLM · Traditional 09/16/1980SE

Questions and answers

When was SMR Paragon Chair Table cleared by the FDA?

SMR Paragon Chair Table (K811623) received a 510(k) decision of Substantially Equivalent on July 2, 1981, 23 days after the submission was received.

What is the product code of K811623?

The FDA product code is LGX – Table, Examination, Medical, Powered, a Class I (low risk) device regulated under 21 CFR 878.4960.