MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter
FDA 510(k) clearance K233553 · decided 2024-06-18
Clearance details
- K-number
- K233553
- Device name
- MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter
- Applicant
- Thayer Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2023-11-06
- Decision date
- 2024-06-18
- Days to decision
- 225 days
- Clearance type
- Special
- 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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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.