The following data is part of a premarket notification filed by Ivac Corporation with the FDA for Ivac Enteral Admin. Sets, Ivac Infusion Pumps.
| Device ID | K946168 |
| 510k Number | K946168 |
| Device Name: | IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS |
| Classification | Pump, Infusion, Enteral |
| Applicant | IVAC CORPORATION 10300 CAMPUS POINT DR. San Diego, CA 92121 |
| Contact | Jennifer S Hankard |
| Correspondent | Jennifer S Hankard IVAC CORPORATION 10300 CAMPUS POINT DR. San Diego, CA 92121 |
| Product Code | LZH |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-19 |
| Decision Date | 1996-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50885403422339 | K946168 | 000 |
| 50885403422049 | K946168 | 000 |
| 50885403274105 | K946168 | 000 |