510(k) K926174
K926174 is an FDA 510(k) premarket notification submitted by Acme Medical Scale Co. for the device "MODEL 9100 H.R. INFANT SCALE". The FDA issued a decision of Substantially Equivalent on October 25, 1993. The device falls under product code FRW (Scale, Patient), a Class I device regulated under 21 CFR 880.2720. Acme Medical Scale Co. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 25, 1993
- Date Received
- December 8, 1992
- 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