510(k) K951902 ยท DQK Computer, Diagnostic, Programmable
PATHFINDER 700 HOLTER ANALYZER
| Applicant | Reynolds Medical , Ltd., Rutherford NJ, US |
| Decision | Substantially Equivalent, Jul 15, 1996 |
| Received | Apr 24, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951902
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 22, 2011 | Spacelabs Healthcare, Llc Pathfinder Holter Analyzer is a Programmable Diagnostic Computer.
The brochure is labeled in part: "***Pathfinder Holter Analyzer ***Spacelabs Healthcare Company Headquarters***5150 220th Ave. SE, I Terminated |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.