The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Endoscopic Insufflation Unit, Model Xecr-2.
| Device ID | K063786 |
| 510k Number | K063786 |
| Device Name: | ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2 |
| Classification | Insufflator, Automatic Carbon-dioxide For Endoscope |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | FCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-21 |
| Decision Date | 2007-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170262562 | K063786 | 000 |
| 04953170239748 | K063786 | 000 |
| 04953170239137 | K063786 | 000 |
| 04953170239120 | K063786 | 000 |
| 04953170239113 | K063786 | 000 |
| 04953170140334 | K063786 | 000 |
| 04953170140327 | K063786 | 000 |
| 04953170338564 | K063786 | 000 |