Demlar Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Demlar Medical, Inc. makes
Demlar Medical, Inc. manufactures computer-based audiometers, including the Demlar SYS I and a high-frequency audiometer model (Delmar #20-K). These devices are designed for clinical hearing assessment, measuring auditory function across different frequencies.
The company’s products are regulated as Class II medical devices in the US and are listed under the FDA’s 510(k) clearance process. The portfolio is authorised for commercial distribution in the United States.
Catalogue
Demlar Sys I Computer Based Audiometer Ref K841167
Regimes: 510(k) Registry: 510(k)High Frequency Audiometer Delmar #20-K Ref K803072
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Demlar Medical, Inc. have in the registry?
The registry currently lists 2 devices for Demlar Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Demlar Medical, Inc.'s devices?
Among its 2 most recently registered devices, Demlar Medical, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Demlar Medical, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Demlar Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Demlar Medical, Inc. in the registry?
The most recently registered devices listed for Demlar Medical, Inc. include DEMLAR SYS I COMPUTER BASED AUDIOMETER and HIGH FREQUENCY AUDIOMETER DELMAR #20-K.