Identifiers
- 510(k) Number
- K153046 FDA 510(k)
- FDA Product Code
- CBK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5895 FDA 510(k)
- Regulation Number
- 868.5895 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The HAMILTON-MR1 is a continuous ventilator designed for facility use, classified as a Class II medical device under FDA regulation 868.5895. It is intended for use in anesthesiology settings to provide mechanical ventilation support to patients requiring respiratory assistance.
The device received FDA 510(k) clearance (K153046) on September 6, 2016, as substantially equivalent to a predicate device. It is manufactured by Hamilton Medical AG in Bonaduz, Switzerland, and is supplied as a reusable system for clinical use in healthcare facilities.
Frequently asked questions
What is the HAMILTON-MR1 used for?
The HAMILTON-MR1 is intended for use in anesthesiology settings to provide mechanical ventilation support to patients requiring respiratory assistance in healthcare facilities.
Is the HAMILTON-MR1 a single-use or reusable device?
The HAMILTON-MR1 is supplied as a reusable system for clinical use in healthcare facilities, meaning it is designed for multiple uses after proper cleaning and reprocessing.
How was the HAMILTON-MR1 authorized for market release?
The HAMILTON-MR1 received FDA 510(k) clearance (K153046) on September 6, 2016, as substantially equivalent to a predicate device under regulation 868.5895.
Who manufactures the HAMILTON-MR1 and where is it produced?
The HAMILTON-MR1 is manufactured by Hamilton Medical AG in Bonaduz, Switzerland, at the address Via Crusch 8, 7402 Bonaduz, CH.
What regulatory classification does the HAMILTON-MR1 have?
The HAMILTON-MR1 is classified as a Class II medical device under FDA regulation 868.5895 for continuous facility-use ventilators.
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 | K153046 | Class II | Active |
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Manufacturer
- Manufacturer
- Hamilton Medical AG
Sources (1)
- FDA 510(k) K153046 24 fields · synced Sep 23, 2026