510(k) K121542
K121542 is an FDA 510(k) premarket notification submitted by Picis, Inc. for the device "PICIS WEIGHT BASED DOSE CONVERTER". The FDA issued a decision of Substantially Equivalent on August 27, 2012. The device falls under product code NDC (Calculator, Drug Dose), a Class II device regulated under 21 CFR 868.1890. Picis, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 2012
- Date Received
- May 24, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calculator, Drug Dose
- Device Class
- Class II
- Regulation Number
- 868.1890
- Review Panel
- CH
- Submission Type