MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR
FDA 510(k) clearance K111570 · decided 2011-09-29
Clearance details
- K-number
- K111570
- Device name
- MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR
- Applicant
- Thayer Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2011-06-06
- Decision date
- 2011-09-29
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- CAF
- Device class
- 2
- Regulation number
- 868.5630
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Tucson, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm O.D./I.D. recall (Z-1146-2017) | Thayer Medical Corporation | 2017-02-07 |