IREX SYSTEM II 2D/DOPPLER IMAGING SYSTEM
FDA 510(k) clearance K827370 · decided 1982-06-28
Clearance details
- K-number
- K827370
- Device name
- IREX SYSTEM II 2D/DOPPLER IMAGING SYSTEM
- Applicant
- Irex Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-04-12
- Decision date
- 1982-06-28
- Days to decision
- 77 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Ramsey, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.