510(k) K844570
K844570 is an FDA 510(k) premarket notification submitted by Keta Corp. for the device "QUANTUM 412". The FDA issued a decision of Substantially Equivalent on December 5, 1984. The device falls under product code HPT (Perimeter, Automatic, Ac-Powered), a Class I device regulated under 21 CFR 886.1605. Keta Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 1984
- Date Received
- November 23, 1984
- 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