510(k) clearances

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

Acula Technology Corp. · Radiology

K233336Substantially EquivalentTraditionalPGY
Open FDA's page for this record
Third party flag
N
City
Taoyuan
Advisory committee description
Radiology
Address 1
11, Aly. 21, Ln. 20, Rd. Dashing, Luchu Dist.
Statement or summary
Summary
Product code
PGY
Zip code
33862
Applicant
Acula Technology Corp.
Decision date
2024-05-21
Decision code
SESE
Country code
TW
Device name
21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01)
Advisory committee
RA
Contact
Sheng-Sung Jian
K number
K233336
Date received
2023-09-29
Review advisory committee
RA
Postal code
33862
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Display, Diagnostic Radiology
Medical specialty description
Radiology
Regulation number
892.2050
Device class
2
Registration number
3024689474, 3009553444, 3013501671, 3006615210, 3031232523, 3024137003, 3004434200, 3016696283, 9613188, 3010043098, 3015976667, 3007817002, 3013084615, 1000207387, 3024897454, 3003032840, 3008481104, 1000181154, 3000237660
FEI number
3024689474, 3009553444, 3013501671, 3006615210, 3031232523, 3024137003, 3004434200, 3016696283, 3010043098, 3015976667, 3007817002, 3013084615, 1000207387, 3004455125, 3024897454, 3003032840, 3008481104, 1000181154, 3000237660
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.