Identity
- Trade Name
- Phased array probe FDA UDI
- Generic Name
- Foetal Doppler system probe FDA UDI
- Model / Reference
- D6P64L FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945121400251 FDA UDI
- 510(k) Number
- K153085 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Foetal Doppler system probe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Foetal Doppler system probe
Phased array probe by CHISON Medical Technologies Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Foetal Doppler system probe.
- T2M20S8C — Koven Technology, Inc. · Class II
- CONTEC — Contec Medical Systems Co., Ltd. · Class II
- Hi-dop — Bistos Co., Ltd. · Class II
- CONTEC — Contec Medical Systems Co., Ltd. · Class II
- US Transducer — Edan Instruments, Inc. · Class II
- Hi-bebe — Bistos Co., Ltd. · Class II
- Hi-bebe — Bistos Co., Ltd. · Class II
- Paryvara — BOOT REMEDY LTD · Class II
Cleared under the same submission
K153085 also covers:
- CHISON iVis Series & Q Series, i3 Diagnostic Ultrasound Systems — CHISON Medical Technologies Co., Ltd.
- Convex probe — CHISON Medical Technologies Co., Ltd.
- Convex probe — CHISON Medical Technologies Co., Ltd.
- Convex probe — CHISON Medical Technologies Co., Ltd.
- Linear probe — CHISON Medical Technologies Co., Ltd.
- Linear probe — CHISON Medical Technologies Co., Ltd.
- Linear probe — CHISON Medical Technologies Co., Ltd.
- Linear probe — CHISON Medical Technologies Co., Ltd.
- Linear probe — CHISON Medical Technologies Co., Ltd.
- Linear probe — CHISON Medical Technologies Co., Ltd.
- Linear probe — CHISON Medical Technologies Co., Ltd.
- Micro convex probe — CHISON Medical Technologies Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CHISON Medical Technologies Co., Ltd.
Sources (1)
- FDA UDI 1deccb1d-6375-4cf7-97c3-70d996cd36d3 33 fields · synced May 31, 2026