Submission Details
| 510(k) Number | K920069 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 07, 1992 |
| Decision Date | March 02, 1992 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
MAGNI-CAM
Mar 1992
Decision
55d
Days
Class 1
Risk
About This 510(k) Submission
K920069 is an FDA 510(k) clearance for the MAGNI-CAM, a System, Reading, Television, Closed-circuit (Class I — General Controls, product code HJG), submitted by Innoventions, Inc. (Ltttleton, US). The FDA issued a Cleared decision on March 2, 1992, 55 days after receiving the submission on January 7, 1992. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5820.
Device Classification
| Product Code | HJG — System, Reading, Television, Closed-circuit |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 886.5820 |
Manufacturer
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