510(k) K870032
K870032 is an FDA 510(k) premarket notification submitted by Sentek, Inc. for the device "REVISED T-SCAN SYSTEM". The FDA issued a decision of Substantially Equivalent on Feb 2, 1987. The device falls under product code EFH (Paper, Articulation), a Class I device regulated under 21 CFR 872.6140.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 2, 1987
- Date Received
- Jan 5, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Paper, Articulation
- Device Class
- Class I
- Regulation Number
- 872.6140
- Review Panel
- DE
- Submission Type
- 510(k) Exempt