CORNEOMAP 4500 ULTRASOUND MEASUREMENT
FDA 510(k) clearance K837331 · decided 1983-05-09
Clearance details
- K-number
- K837331
- Device name
- CORNEOMAP 4500 ULTRASOUND MEASUREMENT
- Applicant
- Radionics Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-03-10
- Decision date
- 1983-05-09
- Days to decision
- 60 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Scarborough, Ontario, Can, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.