Singer Medical Products, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Singer Medical Products, Inc. makes
Singer Medical Products, Inc. manufactures audiometers and impedance analyzers for hearing assessment, including models like the MD-1, MD-3, and MD-4 series, as well as modified nerve stimulators such as the Axostim and its variations. These devices are designed for clinical use in measuring hearing thresholds and impedance, aiding in audiological evaluations and nerve function testing.
The company’s portfolio consists of Class II medical devices, all of which are listed via the FDA’s 510(k) pathway. These devices are regulated under U.S. jurisdiction, adhering to the requirements for Class II authorization. The manufacturer is based in the United States.
Catalogue
Impedance Anal/Screening Audiometer Md-1 & Md-1P Ref K894748
Regimes: 510(k) Registry: 510(k)Modified Axostim Ref K896368
Regimes: 510(k) Registry: 510(k)Axostim Ref K883807
Regimes: 510(k) Registry: 510(k)Axostim Nerve Stimulator, Modification Ref K905035
Regimes: 510(k) Registry: 510(k)MD5 Automatic Audiometer Ref K896909
Regimes: 510(k) Registry: 510(k)Audiometer Model Md-4, Md-4P Ref K895785
Regimes: 510(k) Registry: 510(k)Impedance Analyzer Models Md-2, Md-P Ref K895783
Regimes: 510(k) Registry: 510(k)Impedance Analyzer/Audiometer Model Md-3 Ref K895784
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Singer Medical Products, Inc. have in the registry?
The registry currently lists 8 devices for Singer Medical Products, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Singer Medical Products, Inc.'s devices?
Among its 8 most recently registered devices, Singer Medical Products, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Singer Medical Products, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Singer Medical Products, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Singer Medical Products, Inc. in the registry?
The most recently registered devices listed for Singer Medical Products, Inc. include IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P, MODIFIED AXOSTIM, AXOSTIM and AXOSTIM NERVE STIMULATOR, MODIFICATION.