PATIENT TEMPERATURE MONITOR, MODEL 1000
FDA 510(k) clearance K874159 · decided 1987-11-23
Clearance details
- K-number
- K874159
- Device name
- PATIENT TEMPERATURE MONITOR, MODEL 1000
- Applicant
- Sonodyne America, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1987-10-13
- Decision date
- 1987-11-23
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Morrisville, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.