TEMPERATURE MONITOR 130/131/133
FDA 510(k) clearance K812037 · decided 1981-07-28
Clearance details
- K-number
- K812037
- Device name
- TEMPERATURE MONITOR 130/131/133
- Applicant
- Medix Medical Electronics (U.S.A.), Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-07-21
- Decision date
- 1981-07-28
- Days to decision
- 7 days
- Clearance type
- Traditional
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.