UC IMU B
FDA 510(k) clearance K904137 · decided 1990-11-21
Clearance details
- K-number
- K904137
- Device name
- UC IMU B
- Applicant
- Eucardio Laboratory, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-09-06
- Decision date
- 1990-11-21
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- DFC
- Device class
- 2
- Regulation number
- 866.5600
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.