Patient Monitor, models LM-8, LM-10, LM-12 and LM-15
FDA 510(k) clearance K221879 · decided 2022-08-10
Clearance details
- K-number
- K221879
- Device name
- Patient Monitor, models LM-8, LM-10, LM-12 and LM-15
- Applicant
- Caf Medical Solutions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-06-28
- Decision date
- 2022-08-10
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Hockley, TX, 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.