MTI PHOTOSCREENER
FDA 510(k) clearance K934880 · decided 1994-04-06
Clearance details
- K-number
- K934880
- Device name
- MTI PHOTOSCREENER
- Applicant
- Medical Technology and Innovations, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-10-12
- Decision date
- 1994-04-06
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- MMF
- Device class
- 2
- Regulation number
- 886.1120
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Cedar Falls, IA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medical Technology and Innovations
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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.