Identifiers
- 510(k) Number
- K931899 FDA 510(k)
- FDA Product Code
- CAC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5830 FDA 510(k)
- Regulation Number
- 868.5830 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Davol ATS is an Autotransfusion Apparatus, which is a medical device used in Anesthesiology. It is classified as a class 2 device. The device is used for autotransfusion, which is a medical procedure.
The Davol ATS is supplied with various registration numbers, including 9612051, 9680841, and 3004142400. It has an FDA 510K authorization and is regulated under regulation number 868.5830. The device is associated with the medical specialty of Anesthesiology and has a product code of CAC.
Frequently asked questions
What is the DAVOL ATS used for?
The DAVOL ATS is used for autotransfusion, a medical procedure in the field of Anesthesiology.
Is the DAVOL ATS a single-use device?
The device data does not specify whether the DAVOL ATS is for single-use or reuse, it is classified as a class 2 device.
What are the registration numbers for the DAVOL ATS?
The DAVOL ATS has registration numbers including 9612051, 9680841, and 3004142400.
What is the regulatory classification of the DAVOL ATS?
The DAVOL ATS is regulated under regulation number 868.5830 and has a product code of CAC.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K931899 | Class II | Active |
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Manufacturer
- Manufacturer
- Davol Inc.
- FDA Applicant
- Davol, Inc.
Sources (1)
- FDA 510(k) K931899 24 fields · synced Sep 24, 2026