510(k) K915897
K915897 is an FDA 510(k) premarket notification submitted by Wrm Computers for the device "FPL". The FDA issued a decision of Substantially Equivalent on April 7, 1992. The device falls under product code IKE (Transducer, Miniature Pressure), a Class I device regulated under 21 CFR 890.1615. Wrm Computers has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 7, 1992
- Date Received
- November 25, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Miniature Pressure
- Device Class
- Class I
- Regulation Number
- 890.1615
- Review Panel
- PM
- Submission Type