SMR H-Chair

FDA 510(k) K800526 · Surgical Mechanical Research, Inc.

Substantially Equivalent

510(k) numberK800526

Submission

Device name
SMR H-Chair
Applicant
Surgical Mechanical Research, Inc.
Mchenry, IL, US
Received
March 7, 1980
Decision date
March 18, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
ETF – Unit, Examining/Treatment, Ent
Device class
Class I (low risk)
Regulation
21 CFR 874.5300
Specialty
Ear, Nose, Throat

Other 510(k)s with product code ETF

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K953457Jedmed Spectrum ENT CabinetETF · Traditional Jedmed Instrument Co.08/11/1995SE
K945395Premier Mirror WarmerETF · Traditional Premier Dental Products Co.01/18/1995SE
K932470Langgasse 90ETF · Traditional Happersberger Otopront GmbH08/25/1993SE
K911901Maxi Cabinet Optional Built in S6000 Light SourceETF · Traditional Stortz07/26/1991SE
K910781#491 Power Otolaryngoly CH/#498 Proced CTR & AccesETF · Traditional Midmark Corp.05/15/1991SE
K910243Mobile Treatment CartETF · Traditional Jedmed Instrument Co.04/17/1991SE
K896298Jedmed S ChairETF · Traditional Jedmed Instrument Co.01/26/1990SE
K896273Systema ENT CabinetETF · Traditional Jedmed Instrument Co.01/26/1990SE
K881958Jedmed Maxim ENT CabinetETF · Traditional Jedmed Instrument Co.07/15/1988SE
K860940Micromedics Sterile, Disposable ENT Exam KitETF · Traditional Micromedics, Inc.05/02/1986SE

More from Micromedics, Inc.

510(k)DeviceDecision
K803195System 1 Instrument StandHMF · Traditional 02/04/1981SE
K800382Clear-View Mirror WarmerGET · Traditional 05/14/1980SE
K781801Maxi-ChairHME · Traditional 11/03/1978SE

Questions and answers

When was SMR H-Chair cleared by the FDA?

SMR H-Chair (K800526) received a 510(k) decision of Substantially Equivalent on March 18, 1980, 11 days after the submission was received.

What is the product code of K800526?

The FDA product code is ETF – Unit, Examining/Treatment, Ent, a Class I (low risk) device regulated under 21 CFR 874.5300.