OCULAR BIOMETER 4000
FDA 510(k) clearance K827035 · decided 1982-07-22
Clearance details
- K-number
- K827035
- Device name
- OCULAR BIOMETER 4000
- Applicant
- Radionics Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-04-23
- Decision date
- 1982-07-22
- Days to decision
- 90 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Ontario L3r 1g2, CA
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Radionics Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.