Andromed, Inc.
CanadaFDA applicant, unverified
- Devices
- 5
What Andromed, Inc. makes
Andromed, Inc. manufactures respiratory monitoring devices, including the ANDROFLOW respiratory rate monitor, biological sound monitoring sensors, and electronic stethoscopes like the STETHOS, Agilent models M4532A and M4533A, and the I-STETHOS Link. These products are designed for clinical assessment of lung sounds and respiratory parameters.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. They are based in the United States.
Catalogue
Androflow - Respiratory Rate Monitor Ref K051779
Regimes: 510(k) Registry: 510(k)Biological Sound Monitor (Bsm) Sensor Ref K021389
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
I-Stethos Link Ref K022298
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Andromed, Inc. have in the registry?
The registry currently lists 5 devices for Andromed, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Andromed, Inc.'s devices?
Among its 5 most recently registered devices, Andromed, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Andromed, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Andromed, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Andromed, Inc. in the registry?
The most recently registered devices listed for Andromed, Inc. include ANDROFLOW - RESPIRATORY RATE MONITOR, BIOLOGICAL SOUND MONITOR (BSM) SENSOR, STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX and AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A.