510(k) K930937
K930937 is an FDA 510(k) premarket notification submitted by Vismed, Inc. for the device "LD 400". The FDA issued a decision of Substantially Equivalent on October 18, 1993. The device falls under product code HPT (Perimeter, Automatic, Ac-Powered), a Class I device regulated under 21 CFR 886.1605. Vismed, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 1993
- Date Received
- February 23, 1993
- 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