510(k) K910055
K910055 is an FDA 510(k) premarket notification submitted by Acme Medical Scale Co. for the device "ACME MODEL 8500 WHEELCHAIR SCALE". The FDA issued a decision of Substantially Equivalent on January 14, 1991. The device falls under product code INF (Scale, Platform, Wheelchair), a Class I device regulated under 21 CFR 890.3940. Acme Medical Scale Co. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 14, 1991
- Date Received
- January 7, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scale, Platform, Wheelchair
- Device Class
- Class I
- Regulation Number
- 890.3940
- Review Panel
- PM
- Submission Type