R.E. Brown Co., Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 10
What R.E. Brown Co., Inc. makes
The company manufactures cardiac pacemaker systems, including battery-powered STILITH cardiac pacemakers (models M.60 and M.120) and a range of pacing leads designed for various implantation sites and configurations. Pacing leads include models like MAM 1260, MAM 1290, BUS 860, and MVM 860, as well as specialized adapters such as ACV 14 and ACS 16 for connecting leads to pacemakers. Additional pacing leads (e.g., MDM 1060, MUM 860) and adapters (e.g., ADB 21) are also part of the portfolio.
The portfolio includes devices classified as Class II and Class III under FDA regulations, with submissions recorded in the FDA 510(k) registry. These products are intended for use in the U.S. market and are subject to regulatory oversight for pacemakers and related leads.
Catalogue
Stilith Cardiac Pacemakers-M. 60 & 120 Ref K780781
510(k) 510(k)Pacing Lead Models, Mam 1260 Mam 1290 Ref K781621
510(k) 510(k)Pacing Lead Model Bus 860, Bus 890 Ref K781624
510(k) 510(k)Pacing Lead Adapter, Acv 14, Acv 23 Ref K781626
510(k) 510(k)Pacing Lead Models, Mdm 1060, Mdm 1090 Ref K781620
510(k) 510(k)Pacing Lead Model Mvm 860, Mvm 890 Ref K781625
510(k) 510(k)Pacing Models Mum 860, Mum 890 Ref K781623
510(k) 510(k)Pacing Lead Adapter Model Acs 16 Ref K781622
510(k) 510(k)Pacing Lead Models SA, 350, Sam 500 Ref K781619
510(k) 510(k)Pacing Lead Adapter Model Adb 21 Ref K781627
510(k) 510(k)
Frequently asked questions
How many devices does R.E. Brown Co., Inc. have in the registry?
The registry currently lists 10 devices for R.E. Brown Co., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list R.E. Brown Co., Inc.'s devices?
Among its 10 most recently registered devices, R.E. Brown Co., Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do R.E. Brown Co., Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for R.E. Brown Co., Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from R.E. Brown Co., Inc. in the registry?
The most recently registered devices listed for R.E. Brown Co., Inc. include STILITH CARDIAC PACEMAKERS-M. 60 & 120, PACING LEAD MODELS, MAM 1260 MAM 1290, PACING LEAD MODEL BUS 860, BUS 890 and PACING LEAD ADAPTER, ACV 14, ACV 23.