510(k) K955357
K955357 is an FDA 510(k) premarket notification submitted by Olympic Medical Corp. for the device "OLYMPIC SMART SCALE MODEL 50/50RA". The FDA issued a decision of Substantially Equivalent on Jan 30, 1996. The device falls under product code FRW (Scale, Patient), a Class I device regulated under 21 CFR 880.2720. Olympic Medical Corp. has 36 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 30, 1996
- Date Received
- Oct 23, 1995
- 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
- 510(k) Exempt