The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Evis Exera Iii Video System.
Device ID | K112680 |
510k Number | K112680 |
Device Name: | EVIS EXERA III VIDEO SYSTEM |
Classification | Colonoscope And Accessories, Flexible/rigid |
Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
Contact | Stacy Abbatiello Kluesner |
Correspondent | Stacy Abbatiello Kluesner OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
Product Code | FDF |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-09-14 |
Decision Date | 2012-02-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04953170363696 | K112680 | 000 |
04953170305139 | K112680 | 000 |
04953170305153 | K112680 | 000 |
04953170305177 | K112680 | 000 |
04953170305191 | K112680 | 000 |
04953170305214 | K112680 | 000 |
04953170305238 | K112680 | 000 |
04953170305252 | K112680 | 000 |
04953170305276 | K112680 | 000 |
04953170305290 | K112680 | 000 |
04953170334115 | K112680 | 000 |
04953170334160 | K112680 | 000 |
04953170334184 | K112680 | 000 |
04953170343360 | K112680 | 000 |
04953170363672 | K112680 | 000 |
04953170305115 | K112680 | 000 |