510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Acare Technology Co., Ltd.

New Taipei City, TW

ACARE TECHNOLOGY CO., LTD. appears in FDA device records in New Taipei City, TW. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for Acare Technology Co., Ltd. between 2011 and 2019. The busiest year on record is 2011, with 1. The most recent is 2019, with 1.

Clearances by year, as a table
510(k) clearance decisions for Acare Technology Co., Ltd., by decision year
YearClearances
20111
20191
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K182950Acare Suction UnitJCXSubstantially Equivalent
K111617PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1DQASubstantially Equivalent

Registered establishments

FDA registered establishments for Acare Technology Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30063954473006395447ACARE TECHNOLOGY CO., LTD.5F-4, No.24, Wuquan 2nd Rd, New Taipei City 242 TW2026and 1 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

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Data as of , FDA export datePage updated Source: openFDA, public domain