The following data is part of a premarket notification filed by Hitachi Medical Corp. Of America with the FDA for Eup-ol334 Laparascopicprobe.
| Device ID | K981434 |
| 510k Number | K981434 |
| Device Name: | EUP-OL334 LAPARASCOPICPROBE |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | HITACHI MEDICAL CORP. OF AMERICA 19030 PORTOS DR. Saratoga, CA 95070 |
| Contact | Charles F Hottinger |
| Correspondent | Charles F Hottinger HITACHI MEDICAL CORP. OF AMERICA 19030 PORTOS DR. Saratoga, CA 95070 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-21 |
| Decision Date | 1998-07-27 |
| Summary: | summary |