510(k) K862338
K862338 is an FDA 510(k) premarket notification submitted by Brytech, Inc. for the device "SENSORY 6". The FDA issued a decision of Substantially Equivalent on September 3, 1986. 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
- September 3, 1986
- Date Received
- June 20, 1986
- 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