510(k) K983533 ยท GWQ Full-Montage Standard Electroencephalograph
ACTIWATCH
| Applicant | Mini-Mitter Co., Inc., Sunriver OR, US |
| Decision | Substantially Equivalent, Mar 23, 1999 |
| Received | Oct 8, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983533
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 17, 2008 | Mini-Mitter Company, Inc. Actiwatch 16 Part Number 198-0300-00, Actiwatch 16 AM 198-0300-AM; Actiwatch 64 Part Number 198-0301-00; Actiwatch 64 AM Part Number 198-0301-AM, Mini Mitter, a Respironics Company, Bend, Oregon Terminated |
M | None listed |
| Jan 17, 2008 | Mini-Mitter Company, Inc. Actiwatch 64 AM, Bandless Part Number 198-0301-AM1, Respironics, Inc., Mini Mitter, a Respironics Company, Bend, Oregon Terminated |
M | None listed |
| Jan 17, 2008 | Mini-Mitter Company, Inc. Actiwatch 16, Basic Startup pkg 198-1010-00; and Actiwatch 64, Basic Startup pkg Part Number 198-1000-00. Terminated |
M | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.