S-Scort Duet Model 2014 Portable Suction Pump
FDA 510(k)Class II (US FDA 510(k))
by Sscor, Inc.
Identifiers
- 510(k) Number
- K945929 FDA 510(k)
- FDA Product Code
- BTA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4780 FDA 510(k)
- Regulation Number
- 878.4780 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The S-Scort Duet Model 2014 is a portable suction pump designed for medical facilities. It provides effective emergency suction for acute care facilities, patient transport, and as a backup in medical settings.
This device is powered by 100V-240V AC with a 12V DC battery backup. It is intended for use in hospital crash carts and various care facilities. The device has FDA 510K clearance with product code BTA and is classified as a Class II medical device.
Frequently asked questions
What is the S-Scort Duet Model 2014 Portable Suction Pump used for?
The S-Scort Duet Model 2014 is a portable suction pump designed for medical facilities to provide effective emergency suction in acute care settings, patient transport, and as a backup in various medical environments.
How is the S-Scort Duet Model 2014 powered?
This device is powered by 100V-240V AC with a 12V DC battery backup, making it suitable for use in hospital crash carts and various care facilities where reliable power sources may not always be available.
What is the regulatory classification of the S-Scort Duet Model 2014?
The S-Scort Duet Model 2014 has FDA 510K clearance with product code BTA and is classified as a Class II medical device, indicating it meets specific regulatory requirements for safety and effectiveness.
Is the S-Scort Duet Model 2014 suitable for use in different medical specialties?
Yes, the device has been reviewed by the General and Plastic Surgery advisory committee, making it suitable for use in various medical specialties that require portable suction capabilities.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SSCOR Duet Hospital Aspirator, Hospital Portable Suction, SSCOR Product Manuals, SSCOR S Scort Duet Model 2014 Rev A Operating Instructions and ..., PDF COR,INC. - ia803208.us.archive.org
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K945929 | Class II | Active |
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Manufacturer
- Manufacturer
- Sscor, Inc.
- FDA Applicant
- Sscor
Sources (1)
- FDA 510(k) K945929 24 fields · synced Sep 25, 2026