510(k) K864953
K864953 is an FDA 510(k) premarket notification submitted by Dittmar and Penn Corp. for the device "WEIGHMOBILE, IN BED PATIENT WEIGHING SCALE". The FDA issued a decision of Substantially Equivalent on January 21, 1987. The device falls under product code FRW (Scale, Patient), a Class I device regulated under 21 CFR 880.2720. Dittmar and Penn Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 1987
- Date Received
- December 18, 1986
- 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