RESPIRONICS SIMPLYCLEAR DEVICE
FDA 510(k) clearance K122111 · decided 2012-12-31
Clearance details
- K-number
- K122111
- Device name
- RESPIRONICS SIMPLYCLEAR DEVICE
- Applicant
- Respironics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-07-17
- Decision date
- 2012-12-31
- Days to decision
- 167 days
- Clearance type
- Abbreviated
- Product code
- SDT
- Device class
- 2
- Regulation number
- 868.5665
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Murrysville, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SIMEOX 200 Airway Clearance Device (K241091) | Inogen, Inc. | 2024-12-23 |
| VIBRALUNG ACOUSTICAL PERCUSSOR (K133057) | Westmed, Inc. | 2014-05-23 |
Recalls involving this device
No recalls on record reference this clearance.