DEVETHERM— 510(k) K822873
Substantially EquivalentEko Scann AB
FDA 510(k) clearance K822873 for DEVETHERM, Substantially Equivalent on 1983-03-24. Applicant: Eko Scann AB. Device class: 2.
Clearance details
- Applicant
- Eko Scann AB
- Product code
- Code DQB
- Device class
- Class 2
- Regulation
- 21 CFR 870.2750
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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