The following data is part of a premarket notification filed by Phase Medical, Inc. with the FDA for Dc-1 I.v. Dosage Computer.
| Device ID | K884016 |
| 510k Number | K884016 |
| Device Name: | DC-1 I.V. DOSAGE COMPUTER |
| Classification | Medical Computers And Software |
| Applicant | PHASE MEDICAL, INC. 3500 WEST MOORE AVE., SUITE M Santa Ana, CA 92704 |
| Contact | Alan Davidner |
| Correspondent | Alan Davidner PHASE MEDICAL, INC. 3500 WEST MOORE AVE., SUITE M Santa Ana, CA 92704 |
| Product Code | LNX |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-22 |
| Decision Date | 1988-12-20 |