Identity
- Trade Name
- 4 MHz probe, monitoring FDA UDI
- Generic Name
- Noninvasive vascular ultrasound system probe FDA UDI
- Device Name
- 4 MHz probe (2.5 meter cable), click & stay, monitoring, green marking FDA UDI
- Model / Reference
- 4 MHz_M_C&S_g FDA UDI
- Description
- 4 MHz probe (2.5 meter cable), click & stay, monitoring, green marking FDA UDI
Identifiers
- Catalog Number
- 6059 FDA UDI
- Primary DI / UDI-DI
- 04260493310345 FDA UDI
- 510(k) Number
- K051085 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Noninvasive vascular ultrasound 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
No
FDA UDI
Category: Noninvasive vascular ultrasound system probe
4 MHz probe, monitoring by Compumedics Germany GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Noninvasive vascular ultrasound system probe.
- 8.3MHZ PENCIL PROBE 7' — PARKS MEDICAL ELECTRONICS, INC. · Class II
- 8.0MHZ PENCIL PROBE 841/842 — PARKS MEDICAL ELECTRONICS, INC. · Class II
- 9.3MHZ ADULT FLAT PROBE — PARKS MEDICAL ELECTRONICS, INC. · Class II
- BF8M15S8A — Koven Technology, Inc. · Class II
- 9.7MHZ PENCIL PROBE SHLD — PARKS MEDICAL ELECTRONICS, INC. · Class II
- 9.9MHZ ADULT FLAT PROBE — PARKS MEDICAL ELECTRONICS, INC. · Class II
- 8.4MHZ INFANT FLAT PROBE 841-A — PARKS MEDICAL ELECTRONICS, INC. · Class II
- 8.3MHZ PENCIL PROBE — PARKS MEDICAL ELECTRONICS, INC. · Class II
Cleared under the same submission
K051085 also covers:
- 1 MHz Monitoring Adapter — Compumedics Germany GmbH
- 1 MHz probe, handheld — Compumedics Germany GmbH
- 1 MHz probe, monitoring — Compumedics Germany GmbH
- 1 MHz probe, monitoring — Compumedics Germany GmbH
- 1 MHz probe, monitoring — Compumedics Germany GmbH
- 16 MHz probe, 1mm — Compumedics Germany GmbH
- 16 MHz probe, 1mm with adapter cable — Compumedics Germany GmbH
- 16 MHz probe, 2mm — Compumedics Germany GmbH
- 2 MHz probe, handheld — Compumedics Germany GmbH
- 2 MHz probe, monitoring — Compumedics Germany GmbH
- 2 MHz probe, monitoring — Compumedics Germany GmbH
- 2 MHz probe, monitoring, MRI — Compumedics Germany GmbH
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
- Compumedics Germany GmbH
Sources (1)
- FDA UDI 8450b8e7-5341-447d-9455-b6bc716d75ae 36 fields · synced Jun 6, 2026