The following data is part of a premarket notification filed by Picis Inc. with the FDA for Picis Weight Based Dose Converter.
| Device ID | K121542 |
| 510k Number | K121542 |
| Device Name: | PICIS WEIGHT BASED DOSE CONVERTER |
| Classification | Calculator, Drug Dose |
| Applicant | PICIS INC. 1835 MARKET ST, 29TH FLOOR Philadelphia, PA 19103 |
| Contact | Janice Hogan |
| Correspondent | Janice Hogan PICIS INC. 1835 MARKET ST, 29TH FLOOR Philadelphia, PA 19103 |
| Product Code | NDC |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-24 |
| Decision Date | 2012-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851831007016 | K121542 | 000 |
| 00851831007061 | K121542 | 000 |
| 00851831007085 | K121542 | 000 |