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FDA 510(k)

5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500

K-Number: K191137 · 2019-07-02

ApplicantJvckenwood Corporation
Decision Date2019-07-02
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 is a medical device manufactured by Jvckenwood Corporation. It received FDA 510(k) clearance on 2019-07-02 under approval number K191137. The device is classified under product code PGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500?

5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 is a medical device that received FDA 510(k) clearance on 2019-07-02. It is manufactured by Jvckenwood Corporation. The 510(k) number is K191137.

When was 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 approved by the FDA?

5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 received FDA 510(k) clearance on 2019-07-02, under approval number K191137.

What company makes 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500?

5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 is manufactured by Jvckenwood Corporation.

What is the FDA product code for 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500?

The FDA product code for 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 is PGY.

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Related Devices (Code: PGY)

K1633356MP Color LCD Monitor, RadiForce RX660, RX660-AREizo Corporation K1625278MP Color LCD Monitor (C81W+)Shenzhen Beacon Display Technology Co., Ltd. K1624975MP Monochrome LCD Monitor, RadiForce GX550, GX550-AREizo Corporation K1618952MP Color LCD Monitor CCL214 (CL21214)Jvckenwood Corporation K162196Dell UP3216Q with QUBYX PerfectLum bundleQubyx Software Technologies, Inc. K161229Mammo Tomosynthesis (MDMG-5221)Barco N.V.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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