The following data is part of a premarket notification filed by Excel Medical, Inc. with the FDA for 500 Infuser.
| Device ID | K914988 |
| 510k Number | K914988 |
| Device Name: | 500 INFUSER |
| Classification | Pump, Infusion |
| Applicant | EXCEL MEDICAL, INC. P.O. BOX 1353 Asbury Park, NJ 07712 |
| Contact | Margaret Lumia |
| Correspondent | Margaret Lumia EXCEL MEDICAL, INC. P.O. BOX 1353 Asbury Park, NJ 07712 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-06 |
| Decision Date | 1992-04-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887709082717 | K914988 | 000 |