The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Direct Readout Module Accessory.
| Device ID | K861412 |
| 510k Number | K861412 |
| Device Name: | DIRECT READOUT MODULE ACCESSORY |
| Classification | Calculator/data Processing Module, For Clinical Use |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
| Contact | Jeremy S Bruno |
| Correspondent | Jeremy S Bruno E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
| Product Code | JQP |
| CFR Regulation Number | 862.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-15 |
| Decision Date | 1986-05-23 |