The following data is part of a premarket notification filed by Md Scientific Llc with the FDA for Endotool Drug Dose Calculator.
| Device ID | K053137 |
| 510k Number | K053137 |
| Device Name: | ENDOTOOL DRUG DOSE CALCULATOR |
| Classification | Calculator, Drug Dose |
| Applicant | MD SCIENTIFIC LLC 1214 WAREHAM COURT Charlotte, NC 28207 |
| Contact | Shade M Mecum |
| Correspondent | Shade M Mecum MD SCIENTIFIC LLC 1214 WAREHAM COURT Charlotte, NC 28207 |
| Product Code | NDC |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-09 |
| Decision Date | 2006-06-14 |
| Summary: | summary |