Alarm Intercom Door Lock
FDA 510(k)Class II (US FDA 510(k))
by Possum, Inc.
Identifiers
- 510(k) Number
- K770031 FDA 510(k)
- FDA Product Code
- ILQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.3710 FDA 510(k)
- Regulation Number
- 890.3710 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
An Alarm Intercom Door Lock is a powered communication system device classified under Physical Medicine. It functions as a system that combines alarm, intercom, and door locking capabilities in a single powered unit.
This device is supplied as a powered system for use in medical or care environments. It received FDA 510(k) clearance (K770031) on January 12, 1977, and is regulated under 21 CFR 890.3710 with product code ILQ. The device is reusable and requires appropriate cleaning and maintenance per manufacturer instructions.
Frequently asked questions
What is the Alarm Intercom Door Lock used for?
The Alarm Intercom Door Lock functions as a powered communication system that combines alarm, intercom, and door locking capabilities in a single unit, designed for use in medical or care environments to support communication and access control.
How is the Alarm Intercom Door Lock supplied and is it reusable?
The device is supplied as a powered system for use in medical or care environments and is designated as reusable, requiring appropriate cleaning and maintenance according to the manufacturer's instructions to ensure continued safe operation.
What regulatory pathway was used for the Alarm Intercom Door Lock?
The Alarm Intercom Door Lock received FDA 510(k) clearance under submission K770031 on January 12, 1977, and is classified under 21 CFR 890.3710 with product code ILQ, indicating it was found substantially equivalent to a legally marketed predicate device.
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: Online Alarm Clock - vClock, Online Alarm Clock, Online Alarm Clock, Wecker online stellen — kostenlos mit Tönen | Clockfresh, Set Alarm Online – Free Alarm Clock | Alarm.now
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K770031 | Class II | Active |
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Manufacturer
- Manufacturer
- Possum, Inc.
Sources (1)
- FDA 510(k) K770031 24 fields · synced Oct 6, 2026