The following data is part of a premarket notification filed by Parker Hannifin Corp. with the FDA for Asahi Blood/plasma Pump #abp-01a &.
Device ID | K830818 |
510k Number | K830818 |
Device Name: | ASAHI BLOOD/PLASMA PUMP #ABP-01A & |
Classification | Pump, Blood, Extra-luminal |
Applicant | PARKER HANNIFIN CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FIR |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-03-15 |
Decision Date | 1983-04-12 |