The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Endoscopic Ultrasound Center Eu-y0006.
Device ID | K121564 |
510k Number | K121564 |
Device Name: | ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley, PA 18034 -0610 |
Contact | Laura Storms-tyler |
Correspondent | Laura Storms-tyler OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley, PA 18034 -0610 |
Product Code | IYN |
Subsequent Product Code | ITX |
Subsequent Product Code | IYO |
Subsequent Product Code | ODG |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-05-29 |
Decision Date | 2012-10-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04953170343490 | K121564 | 000 |
04953170343384 | K121564 | 000 |
04953170418013 | K121564 | 000 |