INTRAOCULAR ELECTROMAGNET
FDA 510(k) clearance K854870 · decided 1986-02-19
Clearance details
- K-number
- K854870
- Device name
- INTRAOCULAR ELECTROMAGNET
- Applicant
- Mira, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-12-04
- Decision date
- 1986-02-19
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- HPO
- Device class
- 2
- Regulation number
- 886.4440
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SCIENTRONICS 10K EYE MAGNET (K832950) | Scientific Manufacturer | 1983-10-19 |
| DORC INTRAOCULAR ELECTROMAGNET (K830336) | Jedmed Instrument Co. | 1983-03-09 |
Recalls involving this device
No recalls on record reference this clearance.