The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Olympus Jf-um3-7.5/-12 And Cf-um3-7.5/-12.
| Device ID | K900880 |
| 510k Number | K900880 |
| Device Name: | OLYMPUS JF-UM3-7.5/-12 AND CF-UM3-7.5/-12 |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Contact | J Dillon |
| Correspondent | J Dillon OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-26 |
| Decision Date | 1991-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170065262 | K900880 | 000 |