Identity
- Trade Name
- Foot switch FDA UDI
- Generic Name
- Noninvasive vascular ultrasound system, line-powered FDA UDI
- Device Name
- Foot switch USB, +2 functions FDA UDI
- Model / Reference
- Foot_switch_7911 FDA UDI
- Description
- Foot switch USB, +2 functions FDA UDI
Identifiers
- Catalog Number
- 7911 FDA UDI
- Primary DI / UDI-DI
- 04260493313483 FDA UDI
- 510(k) Number
- K051085 FDA UDI
- FDA Product Code
- IYN FDA UDIITX FDA UDI
- GMDN Term
- Noninvasive vascular ultrasound system, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1550 FDA UDI892.1570 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: Invasive vascular ultrasound systemNoninvasive vascular ultrasound system, line-powered
Foot switch by Compumedics Germany GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Compumedics Germany GmbH
Sources (1)
- FDA UDI 71523c16-3a2a-4fb1-bbae-9c59049f352d 36 fields · synced Jun 8, 2026