510(k) K113835 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
DATACAPTOR SYSTEM
| Applicant | Capsule Tech, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Jun 27, 2012 |
| Received | Dec 27, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113835
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 13, 2012 | Capsule Tech Inc. Capsule Neuron Docking Station, a component in the DataCaptor Connectivity System
Catalog Number DC-NU-DS-CK
The Capsule Neuron Docking Station is a component in the DataCaptor Connectivity System. T Terminated |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.