The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Endoscope Position Marking Probe,endoscope Position Detecting Unit.
| Device ID | K134026 |
| 510k Number | K134026 |
| Device Name: | ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT |
| Classification | Spatial Imaging For Display Of Endoscope Position |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley, PA 18034 -0610 |
| Contact | Daphney Germain-kolawole |
| Correspondent | Daphney Germain-kolawole OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | PGU |
| Subsequent Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-30 |
| Decision Date | 2014-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170365478 | K134026 | 000 |
| 04953170077739 | K134026 | 000 |
| 04953170303043 | K134026 | 000 |
| 04953170305641 | K134026 | 000 |
| 04953170305757 | K134026 | 000 |
| 04953170331121 | K134026 | 000 |
| 04953170331145 | K134026 | 000 |
| 04953170353406 | K134026 | 000 |
| 04953170365461 | K134026 | 000 |
| 04953170165757 | K134026 | 000 |