510(k) K120888 ยท GWQ Full-Montage Standard Electroencephalograph
PSG-1100 SLEEP DIAGNOSTIC SYSTEM
| Applicant | Nihon Kohden Corp., Foothill CA, US |
| Decision | Substantially Equivalent, Nov 9, 2012 |
| Received | Mar 23, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120888
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 14, 2021 | Nihon Kohden America Inc PSG-1100 Sleep Diagnostic System.
Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI (01) 04931921108383; Made in Japan
The PSG-1100 Sleep Diagnostic System is a di Open, Classified |
GWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.