510(k) K020197 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
MODIFICATION TO DATACAPTOR
| Applicant | Capsule Technologie, Deer Field IL, US |
| Decision | Substantially Equivalent, Feb 21, 2002 |
| Received | Jan 22, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K020197
| 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 |
| Jun 1, 2011 | Capsule Tech Inc. Capsule Neuron UMPC is a component in the DataCaptor" Connectivity System.
Catalog Number: DC-NU-MPC
Capsule Neuron" UMPC is a bedside device that enables automatic collection of vital signs data th Terminated |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.