MODEL 5400 OPTOKINETIC STIMULATOR
FDA 510(k) clearance K822917 · decided 1982-11-01
Clearance details
- K-number
- K822917
- Device name
- MODEL 5400 OPTOKINETIC STIMULATOR
- Applicant
- Life-Tech Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-10-01
- Decision date
- 1982-11-01
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- HOW
- Device class
- 1
- Regulation number
- 886.1200
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Life-Tech Intl.
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.