510(k) K884540
K884540 is an FDA 510(k) premarket notification submitted by Sevrain-Tech, Inc. for the device "ETV, ELECTRONIC VISION AID". The FDA issued a decision of Substantially Equivalent on January 19, 1989. The device falls under product code HPE (Aid, Vision, Optical, Battery-Powered), a Class I device regulated under 21 CFR 886.5915. Sevrain-Tech, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 19, 1989
- Date Received
- October 28, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Aid, Vision, Optical, Battery-Powered
- Device Class
- Class I
- Regulation Number
- 886.5915
- Review Panel
- OP
- Submission Type