510(k) K893254
K893254 is an FDA 510(k) premarket notification submitted by Dalphi, Inc. for the device "DYNAMIC SYSTEM COMPUTERIZED PODIATRIC ANALYZER". The FDA issued a decision of Substantially Equivalent on January 2, 1990. The device falls under product code KHX (Platform, Force-Measuring), a Class I device regulated under 21 CFR 890.1575.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 2, 1990
- Date Received
- April 28, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Platform, Force-Measuring
- Device Class
- Class I
- Regulation Number
- 890.1575
- Review Panel
- PM
- Submission Type