Data / Medical devices / United States / BSG Corp
BSG Corp: FDA-registered device maker in Acton, MA, United States, 9 510(k) clearances
BSG Corp is registered with the FDA (registration 3006315274) in Acton, MA, United States. It lists 3 device types. The FDA files 9 510(k) clearances under its listings, the newest dated June 19, 2012. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006315274
- Address
- 3 Post Office Square Suite K, Acton, MA, United States, 01720
- Owner or operator
- BSG Corp. (10044125)
- Roles
- Manufacturer
- First device listed
- May 2, 2013
- Registered through
- 2026
- Brand names listed
- HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500, MICROEEG SYSTEM, MODEL 1001, HYDRODOT(TM) NEUROMONITORING SYSTEM WITH E NET(TM) EEG INTERFACE CABLE, MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS, MODEL 1210, MEDIUM E-NET, MODEL 1220, OR E-NET, MODEL 1240, SMALL E NET, MODEL 1700, HYDRO PREP and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Manufacturer | accessdata.fda.gov |
| Full-Montage Standard Electroencephalograph | GWQ | 2 | Manufacturer | accessdata.fda.gov |
| Media, Electroconductive | GYB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 19, 2012 | K112817 | MICROEEG SYSTEM | GWQ | Substantially Equivalent | Bio-Signal Group Corporation | accessdata.fda.gov |
| January 29, 2010 | K092828 | STATNET, MODEL 3100 | GXY | Substantially Equivalent | Hydrodot, Inc. | accessdata.fda.gov |
| May 14, 1997 | K970694 | MODEL 1700, HYDRO PREP | GYB | Substantially Equivalent | Physiometrix, Inc. | accessdata.fda.gov |
| May 10, 1996 | K961609 | MODEL 1220, OR E-NET (54-62 CM) | GXY | Substantially Equivalent | Physiometrix, Inc. | accessdata.fda.gov |
| April 26, 1996 | K960885 | MODEL 1240, SMALL E NET | GXY | Substantially Equivalent | Physiometrix, Inc. | accessdata.fda.gov |
| April 26, 1996 | K960873 | MODEL 1210, MEDIUM E-NET | GXY | Substantially Equivalent | Physiometrix, Inc. | accessdata.fda.gov |
| April 15, 1996 | K960732 | HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500 | GXY | Substantially Equivalent | Physiometrix, Inc. | accessdata.fda.gov |
| October 12, 1995 | K953449 | MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS | GWQ | Substantially Equivalent | Physiometrix, Inc. | accessdata.fda.gov |
| April 24, 1995 | K946318 | MODEL 1001, HYDRODOT(TM) NEUROMONITORING SYSTEM WITH E NET(TM) EEG INTERFACE CABLE | GXY | Substantially Equivalent | Physiometrix, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 29, 2019 | 84305 | Class II | Terminated | HydroDot brand: Wave Prep 4 oz. tubes-Product 1710-03. An electroconductive cream for use with external electrodes - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of t | Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia) | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Cutaneous
- All makers of Full-Montage Standard Electroencephalograph
- All makers of Media, Electroconductive
Updated December 18, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.