AGFA HEARTLAB CARDIOVASCULAR
FDA 510(k) clearance K050228 · decided 2005-02-18
Clearance details
- K-number
- K050228
- Device name
- AGFA HEARTLAB CARDIOVASCULAR
- Applicant
- Heartlab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-02-01
- Decision date
- 2005-02-18
- Days to decision
- 17 days
- Clearance type
- Special
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Westerly, RI, US
- Third-party review
- No
- Expedited review
- No
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