510(k) K915369
K915369 is an FDA 510(k) premarket notification submitted by Advanced Rehabilitative Technology, Inc. for the device "THE EQUALIZER". The FDA issued a decision of Substantially Equivalent on March 22, 1993. The device falls under product code IKE (Transducer, Miniature Pressure), a Class I device regulated under 21 CFR 890.1615. Advanced Rehabilitative Technology, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 22, 1993
- Date Received
- November 27, 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