Tandem Scanning Microscope

FDA 510(k) K912514 · Tandem Scanning Corp.

Substantially Equivalent

510(k) numberK912514

Submission

Device name
Tandem Scanning Microscope
Applicant
Tandem Scanning Corp.
Bethesda, MD, US
Received
June 6, 1991
Decision date
December 16, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HJO – Biomicroscope, Slit-Lamp, Ac-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1850
Specialty
Ophthalmic

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K182306Sunkingdom Slit LampHJO · Traditional Chongqing Sunkingdom Medical Instrument Co., Ltd.11/22/2018SE
K173771IOLMaster 700HJO · Traditional Carl Zeiss Meditec, AG08/24/2018SE
K171877SLM-1ER, SLM-2ER, SLM-3ERHJO · Traditional Chongqing Kanghua Ruiming S&T Co., Ltd.12/21/2017SE
K170470Digital Eye Anterior CameraHJO · Traditional Medimaging Integrated Solution, Inc (Miis)10/06/2017SE
K162778Portable Slit Lamp MicroscopeHJO · Traditional Suzhou Kangjie Medical, Inc.07/21/2017SE
K162684SL 220HJO · Traditional Carl Zeiss Meditec, AG05/31/2017SE

Questions and answers

When was Tandem Scanning Microscope cleared by the FDA?

Tandem Scanning Microscope (K912514) received a 510(k) decision of Substantially Equivalent on December 16, 1991, 193 days after the submission was received.

What is the product code of K912514?

The FDA product code is HJO – Biomicroscope, Slit-Lamp, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1850.