510(k) K823385
K823385 is an FDA 510(k) premarket notification submitted by Oms for the device "ALES". The FDA issued a decision of Substantially Equivalent on March 9, 1983. The device falls under product code HPG (Aid, Vision, Electronic, Battery-Powered), a Class I device regulated under 21 CFR 886.5900.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 9, 1983
- Date Received
- November 15, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Aid, Vision, Electronic, Battery-Powered
- Device Class
- Class I
- Regulation Number
- 886.5900
- Review Panel
- OP
- Submission Type