The following data is part of a premarket notification filed by Metron U.s., Inc. with the FDA for Metron Qa-ids I.v. Pump Tester.
| Device ID | K982020 |
| 510k Number | K982020 |
| Device Name: | METRON QA-IDS I.V. PUMP TESTER |
| Classification | Pump, Infusion |
| Applicant | METRON U.S., INC. P O BOX 4341 Crofton, MD 21114 -4341 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith METRON U.S., INC. P O BOX 4341 Crofton, MD 21114 -4341 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-09 |
| Decision Date | 1998-09-30 |