510(k) K943587
K943587 is an FDA 510(k) premarket notification submitted by Future Systems, Inc. for the device "ADVANCED IN-BED WEIGH SYSTEM". The FDA issued a decision of Substantially Equivalent on September 22, 1994. The device falls under product code FRW (Scale, Patient), a Class I device regulated under 21 CFR 880.2720.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 22, 1994
- Date Received
- July 22, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scale, Patient
- Device Class
- Class I
- Regulation Number
- 880.2720
- Review Panel
- HO
- Submission Type