Burditt & Calkins-Siemens-Elema
Country not established
- Devices
- 10
What Burditt & Calkins-Siemens-Elema makes
The company manufactures medical devices including myocardial temperature sensors for cardiac procedures, remote field units for monitoring, manual breast pumps, temperature-sensing probes, and external pulse generators for cardiac pacing. Additional products include coaxial bipolar pacing electrodes, portable pulse volume recorders, infant feeding devices, and an erectile dysfunction aid.
These devices are classified under FDA categories Class I, Class II, and Class III, with regulatory submissions recorded in the FDA’s 510(k) clearance database. The company operates under US regulatory oversight and is based in the United States.
Catalogue
Mon-A-Therm Myocardial Temp. Sensor Ref K823435
Regimes: 510(k) Registry: 510(k)Informed Remote Field Unit Model IFM1000 Ref K821712
Regimes: 510(k) Registry: 510(k)Ameda Hand Breast Pump Ref K823591
Regimes: 510(k) Registry: 510(k)Terperatur Sensing Device Ref K802607
Regimes: 510(k) Registry: 510(k)Siemens-Elma Pulse Generator #718 Ref K830344
Regimes: 510(k) Registry: 510(k)Erectaid Ref K803111
Regimes: 510(k) Registry: 510(k)Coaxial Bipolar Pacing Electrode Ref K822239
Regimes: 510(k) Registry: 510(k)Rayden Medical Mini Pulse Volume Record Ref K833155
Regimes: 510(k) Registry: 510(k)Liberator/Stroller Ref K760787
Regimes: 510(k) Registry: 510(k)Pulse Generator Model 688 Ref K833519
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Burditt & Calkins-Siemens-Elema have in the registry?
The registry currently lists 10 devices for Burditt & Calkins-Siemens-Elema. Devices recorded under merged duplicate company entries are counted once.
Which registries list Burditt & Calkins-Siemens-Elema's devices?
Among its 10 most recently registered devices, Burditt & Calkins-Siemens-Elema has devices listed in FDA 510(k) (10 devices).
What risk classes do Burditt & Calkins-Siemens-Elema's devices fall under?
Among its 10 most recently registered devices, the classes recorded for Burditt & Calkins-Siemens-Elema's devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Burditt & Calkins-Siemens-Elema in the registry?
The most recently registered devices listed for Burditt & Calkins-Siemens-Elema include MON-A-THERM MYOCARDIAL TEMP. SENSOR, INFORMED REMOTE FIELD UNIT MODEL IFM1000, AMEDA HAND BREAST PUMP and TERPERATUR SENSING DEVICE.