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FDA 510(k)

5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)

K-Number: K160326 · 2016-02-23

ApplicantJvckenwood Corporation
Decision Date2016-02-23
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) is a medical device manufactured by Jvckenwood Corporation. It received FDA 510(k) clearance on 2016-02-23 under approval number K160326. 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 Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)?

5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) is a medical device that received FDA 510(k) clearance on 2016-02-23. It is manufactured by Jvckenwood Corporation. The 510(k) number is K160326.

When was 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) approved by the FDA?

5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) received FDA 510(k) clearance on 2016-02-23, under approval number K160326.

What company makes 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)?

5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) is manufactured by Jvckenwood Corporation.

What is the FDA product code for 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)?

The FDA product code for 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) is PGY.

Other Devices by Jvckenwood Corporation

K1618952MP Color LCD Monitor CCL214 (CL21214) K1734342MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300 K1825392MP Color LCD Monitor CL-R211 K1911375MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 K2001613MP Monochrome Digital Mammography LCD Monitor MS-S300 K2129856MP Color LCD Monitor CL-S600

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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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