The following data is part of a premarket notification filed by Parker Hannifin Corp. with the FDA for Model 2000 Ambulatory Med. Infuser.
Device ID | K833723 |
510k Number | K833723 |
Device Name: | MODEL 2000 AMBULATORY MED. INFUSER |
Classification | Pump, Infusion |
Applicant | PARKER HANNIFIN CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-10-24 |
Decision Date | 1984-01-30 |