510(k) K982612
K982612 is an FDA 510(k) premarket notification submitted by Ironmaster, Inc. for the device "ESP7 VENOUS IMAGE". The FDA issued a decision of Substantially Equivalent on December 14, 1998. The device falls under product code KZA (Device, Vein Location, Liquid Crystal), a Class I device regulated under 21 CFR 880.6970.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 1998
- Date Received
- July 27, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Vein Location, Liquid Crystal
- Device Class
- Class I
- Regulation Number
- 880.6970
- Review Panel
- HO
- Submission Type