Atlas FDA

DORC INTRAOCULAR ELECTROMAGNET

FDA 510(k) clearance K830336 · decided 1983-03-09

Clearance details

K-number
K830336
Device name
DORC INTRAOCULAR ELECTROMAGNET
Applicant
Jedmed Instrument Co.
Decision
Substantially Equivalent
Date received
1983-02-01
Decision date
1983-03-09
Days to decision
36 days
Clearance type
Traditional
Product code
HPO
Device class
2
Regulation number
886.4440
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Mchenry, IL, 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.

RecordFirmDate
INTRAOCULAR ELECTROMAGNET (K854870)Mira, Inc.1986-02-19
SCIENTRONICS 10K EYE MAGNET (K832950)Scientific Manufacturer1983-10-19

Recalls involving this device

No recalls on record reference this clearance.