510(k) K883458
K883458 is an FDA 510(k) premarket notification submitted by Optimed, Inc. for the device "OPTIMED ADVANTAGE". The FDA issued a decision of Substantially Equivalent on November 7, 1988. The device falls under product code HPT (Perimeter, Automatic, Ac-Powered), a Class I device regulated under 21 CFR 886.1605. Optimed, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 7, 1988
- Date Received
- August 12, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Perimeter, Automatic, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 886.1605
- Review Panel
- OP
- Submission Type