510(k) K905235 ยท CBK Ventilator, Continuous, Facility Use
VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS
| Applicant | Percussionaire Corp., Sandpoint ID, US |
| Decision | Substantially Equivalent, May 3, 1991 |
| Received | Nov 7, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905235
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 23, 2025 | Percussionaire Corporation VDR4 Phasitron Breathing Circuit Models that contain the venturi component:
-A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk
-A51001, VDR4 Control Unit Tester
-PRT 991, VDR W/SWIVEL T SINGLE PA Open, Classified |
CBK | None listed |
| Jan 17, 2024 | Percussionaire Corporation Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit) Open, Classified |
CBK | None listed |
| Nov 7, 2023 | Percussionaire Corporation Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators. Completed |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.