Identity
- Trade Name
- Summit Doppler FDA UDI
- Generic Name
- Foetal Doppler system probe FDA UDI
- Device Name
- LifeDop 3.0 MHZ Probe FDA UDI
- Model / Reference
- SD3 FDA UDI
- Description
- LifeDop 3.0 MHZ Probe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937001952 FDA UDI
- 510(k) Number
- K024197 FDA UDI
- FDA Product Code
- KNG FDA UDI
- GMDN Term
- Foetal Doppler system probe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.2660 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
No
FDA UDI
Category: Foetal Doppler system probe
Summit Doppler by CooperSurgical, Inc. — 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
- ECO Series Diagnostic Ultrasound Systems — CHISON Medical Technologies Co., Ltd. · Class II
- Phased array probe — CHISON Medical Technologies Co., Ltd. · Class II
Cleared under the same submission
K024197 also covers:
- 5.0 MHz Deep Vascular Probe — CooperSurgical, Inc.
- 8.0 MHz Superficial Vascular Probe — CooperSurgical, Inc.
- ClearTone Doppler — CooperSurgical, Inc.
- ClearTone Doppler — CooperSurgical, Inc.
- ClearTone Doppler — CooperSurgical, Inc.
- ClearTone Doppler — CooperSurgical, Inc.
- ClearTone Doppler — CooperSurgical, Inc.
- ClearTone Doppler — CooperSurgical, Inc.
- ClearTone Doppler — CooperSurgical, Inc.
- ClearTone Doppler — CooperSurgical, Inc.
- ClearTone Doppler — CooperSurgical, Inc.
- ClearTone Doppler — CooperSurgical, Inc.
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 |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (1)
- FDA UDI e09155ce-3906-44ca-9152-eb977b9dc6d7 34 fields · synced Jun 9, 2026