The following data is part of a premarket notification filed by Lamtic, Inc. with the FDA for Ac-901 I.v. Infusion Drop Counter.
| Device ID | K923561 |
| 510k Number | K923561 |
| Device Name: | AC-901 I.V. INFUSION DROP COUNTER |
| Classification | Monitor, Electric For Gravity Flow Infusion Systems |
| Applicant | LAMTIC, INC. 18 TECHNOLOGY DR., SUITE 138 Irvine, CA 92718 |
| Contact | Alfred M Wu |
| Correspondent | Alfred M Wu LAMTIC, INC. 18 TECHNOLOGY DR., SUITE 138 Irvine, CA 92718 |
| Product Code | FLN |
| CFR Regulation Number | 880.2420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-17 |
| Decision Date | 1993-05-26 |