510(k) K951771
K951771 is an FDA 510(k) premarket notification submitted by Sms Technologies, Ltd. for the device "COMMUNITY BALANCE PERFORMANCE MONITOR OR COMMUNITY BPM". The FDA issued a decision of Substantially Equivalent on August 11, 1995. The device falls under product code KHX (Platform, Force-Measuring), a Class I device regulated under 21 CFR 890.1575. Sms Technologies, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 11, 1995
- Date Received
- April 17, 1995
- 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