MODIFIED MYOCARDIAL TEMPERATURE SENSOR— 510(k) K874522
Substantially EquivalentMon-A-Therm, Inc.
FDA 510(k) clearance K874522 for MODIFIED MYOCARDIAL TEMPERATURE SENSOR, Substantially Equivalent on 1988-01-29. Applicant: Mon-A-Therm, Inc.. Device class: 2.
Clearance details
- Applicant
- Mon-A-Therm, Inc.
- 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
- St. Louis, MO, US
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