MON-A-THERM MYOCARDIAL TEMP. SENSOR— 510(k) K823435
Substantially EquivalentBurditt & Calkins-Siemens-Elema
FDA 510(k) clearance K823435 for MON-A-THERM MYOCARDIAL TEMP. SENSOR, Substantially Equivalent on 1982-12-30. Applicant: Burditt & Calkins-Siemens-Elema. Device class: 2.
Clearance details
- Applicant
- Burditt & Calkins-Siemens-Elema
- Product code
- Code KRB
- Device class
- Class 2
- Regulation
- 21 CFR 870.1915
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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More clearances from Burditt & Calkins-Siemens-Elema
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