The following data is part of a premarket notification filed by Parker Hannifin Corp. with the FDA for Modified Labeling To Model 2000 Ambulatory Infuser.
| Device ID | K863532 |
| 510k Number | K863532 |
| Device Name: | MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER |
| Classification | Pump, Infusion |
| Applicant | PARKER HANNIFIN CORP. 17352 VON KARMAN AVE. Irvine, CA 92614 -6204 |
| Contact | Steve A Wirtz |
| Correspondent | Steve A Wirtz PARKER HANNIFIN CORP. 17352 VON KARMAN AVE. Irvine, CA 92614 -6204 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-09 |
| Decision Date | 1987-01-14 |