510(k) K213335 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Capsule Surveillance System
| Applicant | Capsule Surveillance Technologies, Sas /Capsule Tech, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Jan 14, 2022 |
| Received | Oct 6, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213335
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.