Picis Weight Based Dose Converter
FDA 510(k) K121542 · Picis, Inc.
510(k) numberK121542
Submission
- Device name
- Picis Weight Based Dose Converter
- Applicant
- Picis, Inc.
Philedelphia, PA, US - Received
- May 24, 2012
- Decision date
- August 27, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NDC – Calculator, Drug Dose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1890
- Specialty
- Anesthesiology
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Questions and answers
When was Picis Weight Based Dose Converter cleared by the FDA?
Picis Weight Based Dose Converter (K121542) received a 510(k) decision of Substantially Equivalent on August 27, 2012, 95 days after the submission was received.
What is the product code of K121542?
The FDA product code is NDC – Calculator, Drug Dose, a Class II (moderate risk) device regulated under 21 CFR 868.1890.