Identifiers
- 510(k) Number
- K904766 FDA 510(k)
- FDA Product Code
- BZD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5905 FDA 510(k)
- Regulation Number
- 868.5905 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The DeVilbiss Model 7352 Series is a Class 2 Anesthesiology device with product code BZD, classified as a Ventilator, Non-Continuous (Respirator). It is designed to provide respiratory support in medical settings.
The device is manufactured by DeVilbiss Health Care, Inc. and received FDA 510(k) clearance through the Traditional pathway on March 26, 1991, after a 155-day review. It is authorized for use in anesthesiology applications and is subject to regulation number 868.5905.
Frequently asked questions
What is the DeVilbiss Model 7352 Series used for?
The DeVilbiss Model 7352 Series is a Class 2 Anesthesiology device designed to provide respiratory support in medical settings. It is classified as a Ventilator, Non-Continuous (Respirator) and is authorized for use in anesthesiology applications.
What is the regulatory status of the DeVilbiss Model 7352 Series?
The DeVilbiss Model 7352 Series received FDA 510(k) clearance through the Traditional pathway on March 26, 1991, after a 155-day review. It is subject to regulation number 868.5905 and is classified under product code BZD.
Is the DeVilbiss Model 7352 Series reusable or single-use?
The device data does not specify whether the DeVilbiss Model 7352 Series is reusable or single-use. This information would need to be obtained directly from the manufacturer or product documentation.
What sizes and models are available in the DeVilbiss Model 7352 Series?
The device data does not provide specific information about available sizes or models within the DeVilbiss Model 7352 Series. For detailed specifications on available configurations, you would need to consult the manufacturer directly or refer to the product documentation.
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: Medizinische Hilfsmittel - Drive Medical, K904766 FDA 510 (k) - DEVILBISS MODEL 7352 SERIES, DEVILBISS MODEL 7352 SERIES (K904766) — FDA 510(k) | Innolitics, 510 (k) K904766 — DEVILBISS MODEL 7352 SERIES — RegDataLab, Drive DeVilbiss wird Drive Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K904766 | Class II | Active |
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Manufacturer
- Manufacturer
- Devilbiss Health Care, Inc.
Sources (1)
- FDA 510(k) K904766 24 fields · synced Sep 24, 2026