Thermalog S Steam Sterilization Integra
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K813202 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 Thermalog S Steam Sterilization Integra is a device used for steam sterilization processes. It is classified as an indicator for physical/chemical sterilization processes and is intended for use in general hospital settings.
The device is supplied by Bio-Medical Sciences, Inc. and has FDA 510(k) clearance with the product code JOJ. It is a Class II device and was cleared on December 31, 1981, with the K number K813202.
Frequently asked questions
What is the Thermalog S Steam Sterilization Integra used for?
The Thermalog S Steam Sterilization Integra is a device used as an indicator for physical/chemical sterilization processes in general hospital settings. It helps ensure proper steam sterilization procedures are followed.
How is the Thermalog S Steam Sterilization Integra supplied?
The device is supplied by Bio-Medical Sciences, Inc. It is classified as a Class II device with FDA 510(k) clearance and product code JOJ, indicating it meets specific regulatory requirements for safety and effectiveness.
What is the regulatory status of the Thermalog S Steam Sterilization Integra?
The Thermalog S Steam Sterilization Integra has FDA 510(k) clearance with the K number K813202. It was cleared on December 31, 1981, and is classified as substantially equivalent to predicate devices for steam sterilization indicators.
What type of sterilization process does the Thermalog S Steam Sterilization Integra monitor?
The device specifically monitors steam sterilization processes. It serves as an indicator to confirm that the physical and chemical parameters of the sterilization cycle have been properly achieved during steam sterilization procedures in hospital settings.
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: THERMALOG S STEAM STERILIZATION INTEGRA (K813202) — FDA 510 (k ..., 510(k) K813202 — THERMALOG S STEAM STERILIZATION INTEGRA, Thermalog S Steam Sterilization Integra 510 (k) FDA Premarket ..., Bio-Medical Sciences, Inc. FDA 510 (k) Products (1978-1998), 3M™ Comply™ Thermalog™ Steam Chemical Integrator, 2134MM, Cls 5, 3/4 x ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K813202 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bio-Medical Sciences, Inc.
Sources (1)
- FDA 510(k) K813202 24 fields · synced Sep 28, 2026