The following data is part of a premarket notification filed by Karl Storz Endoscopy with the FDA for Ksea Model 383320 20 Angiomat.
| Device ID | K960486 |
| 510k Number | K960486 |
| Device Name: | KSEA MODEL 383320 20 ANGIOMAT |
| Classification | Withdrawal/infusion Pump |
| Applicant | KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Renate A Maclaren |
| Correspondent | Renate A Maclaren KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | DQI |
| CFR Regulation Number | 870.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-02 |
| Decision Date | 1996-10-25 |
| Summary: | summary |