VIBRALUNG ACOUSTICAL PERCUSSOR
FDA 510(k) clearance K133057 · decided 2014-05-23
Clearance details
- K-number
- K133057
- Device name
- VIBRALUNG ACOUSTICAL PERCUSSOR
- Applicant
- Westmed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-09-27
- Decision date
- 2014-05-23
- Days to decision
- 238 days
- Clearance type
- Traditional
- Product code
- SDT
- Device class
- 2
- Regulation number
- 868.5665
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Tucson, AZ, US
- Third-party review
- No
- Expedited review
- No
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| SIMEOX 200 Airway Clearance Device (K241091) | Inogen, Inc. | 2024-12-23 |
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Recalls involving this device
No recalls on record reference this clearance.