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Oximeter
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref JZK-301Model JZK-301，JZK-303, JZK-305, JZK-307Ref JZK __305510(k) K213984
Identity
- Trade Name
- Oximeter EUDAMED
- Device Name
- Oximeter EUDAMED
- Model / Reference
- JZK-301，JZK-303, JZK-305, JZK-307 EUDAMEDJZK-301 EUDAMEDJZK __305 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922119300199 EUDAMED06922119301448 EUDAMED
- Basic UDI-DI
- 69221193XSY EUDAMED
- Direct Marketing DI
- 06922119300199 EUDAMED
- 510(k) Number
- K213984 FDA 510(k)
- FDA Product Code
- DQA FDA 510(k)
- EMDN Code
- Z12030201 CENTRAL INFORMATION COMPUTING SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2700 FDA 510(k)
- Regulation Number
- 870.2700 FDA 510(k)
- Market of Registration
- France EUDAMEDGermany EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Oximeter by Shenzhen Zhengkang Technology Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213984 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69221193XSY | Class IIa | Active |
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Manufacturer
- Manufacturer
- ShenZhen ZhengKang Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000038997
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED ccba2784-8fec-44d2-8fdb-e271bbf4d27b 61 fields · synced Jul 28, 2026
- EUDAMED 35f6cfb6-de00-4552-83a4-49bb3edeac6c 61 fields · synced May 17, 2026
- FDA 510(k) K213984 24 fields · synced May 18, 2026