VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS
FDA 510(k) clearance K905235 · decided 1991-05-03
Clearance details
- K-number
- K905235
- Device name
- VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS
- Applicant
- Percussionaire Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-11-07
- Decision date
- 1991-05-03
- Days to decision
- 177 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Sandpoint, ID, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, recall (Z-0960-2025) | Percussionaire Corporation | 2025-01-23 |
| Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or contr recall (Z-0693-2024) | Percussionaire Corporation | 2024-01-17 |
| Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators. recall (Z-0259-2024) | Percussionaire Corporation | 2023-11-07 |