ClearanceBrief
510(k) K943509 ยท BZD Ventilator, Non-Continuous (Respirator)

7300 NASAL CPAP SYSTEM

ApplicantHealthdyne Technologies, Inc., Marietta GA, US
DecisionSubstantially Equivalent, Aug 5, 1994
ReceivedJul 20, 1994
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K943509

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.