The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Olympus Angioscopy Pump.
Device ID | K871422 |
510k Number | K871422 |
Device Name: | OLYMPUS ANGIOSCOPY PUMP |
Classification | Withdrawal/infusion Pump |
Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
Contact | Wayne Lipson |
Correspondent | Wayne Lipson OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
Product Code | DQI |
CFR Regulation Number | 870.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-09 |
Decision Date | 1987-08-12 |