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Medical image storage transmission analysis device

์˜๋ฃŒ์˜์ƒ์ €์žฅ์ „์†ก๋ถ„์„์žฅ์น˜

This Class II medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / ์‹ํ’ˆ์˜์•ฝํ’ˆ์•ˆ์ „์ฒ˜) under license number Suin 22-4313. Approved on Jun 16, 2022. Registered by Abbott Medical Korea.

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MFDS Official Data
Class II
Basic Information
Item Serial Number
2022003070
License Number
Suin 22-4313
์ˆ˜์ธ22-4313ํ˜ธ
Classification Number
A26430.04(2)
Device Class (Risk Classification)
Class II
Classification Name
Medical image storage transmission analysis device
์˜๋ฃŒ์˜์ƒ์ €์žฅ์ „์†ก๋ถ„์„์žฅ์น˜
Official English Name
Telemetry system transmitter, analysis
Company Information
Entity Name (Company)
Abbott Medical Korea
์• ๋ณดํŠธ๋ฉ”๋””์นผ์ฝ”๋ฆฌ์•„(์œ )
Entity Address
์„œ์šธํŠน๋ณ„์‹œ ๊ฐ•๋‚จ๊ตฌ ์–ธ์ฃผ๋กœ 337 , ๋™์˜๋ฌธํ™”์„ผํ„ฐ๋นŒ๋”ฉ 4์ธต(์—ญ์‚ผ๋™)[์˜์—…์†Œ1], ์„œ์šธํŠน๋ณ„์‹œ ๊ฐ•๋‚จ๊ตฌ ์˜๋™๋Œ€๋กœ 421, 5์ธต ์ผ๋ถ€(๋Œ€์น˜๋™, ์‚ผํƒ„๋นŒ๋”ฉ)[์˜์—…์†Œ2]
Manufacturer
Abbott Medical
Category
Import business
์ˆ˜์ž…์—…
Business License Number
์ œ 477 ํ˜ธ
Important Dates & Status
Item Approval Date
Jun 16, 2022
Business Permit Date
Apr 26, 2005
Expiration Period
2022-06-16 ~ 2027-06-15
For Export
์•„๋‹ˆ์˜ค
Model Information
Model Name
1014932
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