Albert Browne Ltd. Verify Steam And Eo Load Record Card
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K061738 FDA 510(k)
- FDA Product Code
- JOJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.2800 FDA 510(k)
- Regulation Number
- 880.2800 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Albert Browne Ltd. Verify Steam and Eo Load Record Card is a physical and chemical sterilization process indicator. It contains process indicators that undergo a visual color change when exposed to steam within a temperature range of 121°C to 135°C (250°F to 275°F) or when exposed to an ethylene oxide sterilization process.
This device is used to monitor sterilization cycles and is authorized under FDA 510(k) clearance K061738. It is categorized under the general hospital medical specialty and is regulated under 21 CFR 880.2800.
Frequently asked questions
What is the purpose of the Albert Browne Verify Load Record Card?
This device serves as a physical and chemical sterilization process indicator. It is designed to monitor sterilization cycles by undergoing a visual color change when exposed to specific sterilization conditions.
Which sterilization methods is this indicator compatible with?
The card is compatible with steam sterilization processes within a temperature range of 121°C to 135°C (250°F to 275°F) and ethylene oxide (EO) sterilization processes.
Is this device authorized for use?
Yes, this device is authorized under FDA 510(k) clearance K061738 and is regulated under 21 CFR 880.2800 within the general hospital medical specialty.
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: K061738 FDA 510(k) - ALBERT BROWNE LTD. VERIFY STEAM AND EO ..., Albert Browne Ltd. Verify Steam and Eo Load Record Card, PDF ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD… - FDA.report, Albert Browne , Ltd. FDA 510 (k) Products (1997-2007), Albert Browne Ltd. Verify Steam and Eo Load Record Card
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K061738 | Class II | Active |
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Manufacturer
- Manufacturer
- Albert Browne , Ltd.
Sources (1)
- FDA 510(k) K061738 24 fields · synced Sep 24, 2026