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FDA 510(k)

21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01)

K-Number: K233336 · 2024-05-21

ApplicantAcula Technology Corp.
Decision Date2024-05-21
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01) is the device name listed in this FDA 510(k) record. The listed applicant is Acula Technology Corp.. It received FDA 510(k) clearance on 2024-05-21 under 510(k) number K233336. 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 21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01)?

21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01) is a medical device that received FDA 510(k) clearance on 2024-05-21. The listed applicant is Acula Technology Corp.. The 510(k) number is K233336.

When did 21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01) receive FDA 510(k) clearance?

21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01) received FDA 510(k) clearance on 2024-05-21, under 510(k) number K233336.

Who is the listed applicant for 21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01)?

The FDA 510(k) record lists Acula Technology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01)?

The FDA product code for 21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01) is PGY.

Other records listing Acula Technology Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K24149921.3” 5MP Color LCD Display UMD5-21B01

Related Devices (Code: PGY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261213Medical Monitor (40HT513D)Lg Electronics.IncK252780LCD Monitor (CL1902A, CL2103F)Shenzhen Beacon Display Technology Co., Ltd.K253242LCD Monitor (C1216W, C822W, C821W)Shenzhen Beacon Display Technology Co., Ltd.K252030RadiForce GX570; RadiForce GX570-AREizo CorporationK243221RadiForce RX570; RadiForce RX570-AREizo CorporationK243031LCD Monitors C310S, G310S, C316S, G316S, C616WShenzhen Beacon Display Technology Co., Ltd.

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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