KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM
FDA 510(k) clearance K875334 · decided 1988-03-24
Clearance details
- K-number
- K875334
- Device name
- KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM
- Applicant
- Kontron Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-12-30
- Decision date
- 1988-03-24
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- HGL
- Device class
- 2
- Regulation number
- 884.2960
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Everett, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.