2024年3月14日发(作者：)

ITRI-CMS-Office of Medical Device Evaluation List of devices for 510(k) review

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Database Updated May 5, 2005

Panel CFR Number

000

Regulation Name/Device Name Class

Anesthesiology

1 868.5630

NEBULIZER

霧化治療器

AMMONIA TEST SYSTEM

氨測試系統

BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST

新生兒膽紅素(總量及未結合的)試驗系統

CALIBRATOR

比對標準品

HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM

人類絨毛膜性腺激素

BICARBONATE/CARBON DIOXIDE TEST SYSTEM

二氧化碳測試系統

CHLORIDE TEST SYSTEM

氯化物試驗系統

CREATININE TEST SYSTEM

肌氨酸酐試驗系統

GALACTOSE TEST SYSTEM

半乳糖試驗系統

URINARY GLUCOSE (NONQUANTITATIVE) TEST SYSTEM

II

I

I

II

II

II

II

II

I

II

Clinical Chemistry

2

3

4

5

6

7

8

9

10

862.1065

862.1113

862.1150

862.1155

862.1160

862.1170

862.1225

862.1310

862.1340

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ITRI-CMS-Office of Medical Device Evaluation List of devices for 510(k) review

尿中血糖(非量化)測試系統

11

12

13

14

15

16

862.1345

862.1410

862.1415

862.1495

862.1580

862.1600

GLUCOSE TEST SYSTEM

血糖測試系統

IRON (NON-HEME) TEST SYSTEM

鐵(非原血紅素)測試系統

IRON-BINDING CAPACITY TEST BINDING

鐵結合能力測試系統

MAGNESIUM TEST SYSTEM

鎂測試系統

PHOSPHORUS (INORGANIC) TEST SYSTEM

亞磷酸(無機)測試系統

POTASSIUM TEST SYSTEM

鉀測試系統

QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAY)

品管物質(分析與非分析)

SODIUM TEST SYSTEM

鈉測試系統

TESTOSTERONE TEST SYSTEM

睪丸酮試驗系統

FREE TYROSINE TEST SYSTEM

游離酥氨基酸試驗系統

UREA NITROGEN TEST SYSTEM

尿素測試系統

URIC ACID TEST SYSTEM

尿酸測試系統

BLOOD PRESSURE CUFF

壓脈帶式血壓計

NONINVASIVE BLOOD PRESSURE MEASUREMENT

非侵入式血壓量測系統

CARDIAC MONITOR (INCLUDING CARDIOTACHOMETER

心臟監視器(心音、心跳警告功能)

ECHOCARDIOGRAPH

超音波心臟照影計

ELECTROCARDIOGRAPH

心電圖機

ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR

28 870.2350

心電圖導程切換接頭

ELECTROCARDIOGRAPH ELECTRODE

29 870.2360

心電圖機電極片

II

II

II

I

I

I

I

II

17 862.1660 I

18 862.1665 II

19

20

21

22

862.1680

862.1730

862.1770

862.1775

I

I

II

I

Cardiovascular

23

24

25

26

27

870.1120

870.1130

870.2300

870.2330

870.2340

II

II

II

II

II

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