The following data is part of a premarket notification filed by Intelligent Medicine, Inc. with the FDA for Intelligraph(tm) Programmer.
| Device ID | K861598 |
| 510k Number | K861598 |
| Device Name: | INTELLIGRAPH(TM) PROGRAMMER |
| Classification | Pump, Infusion |
| Applicant | INTELLIGENT MEDICINE, INC. 6665 S. KENTON, STE 201 Englewood, CO 80111 |
| Contact | David C Howson |
| Correspondent | David C Howson INTELLIGENT MEDICINE, INC. 6665 S. KENTON, STE 201 Englewood, CO 80111 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-29 |
| Decision Date | 1986-07-24 |