The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Systems Integration Model: Endoalpha.
| Device ID | K100345 |
| 510k Number | K100345 |
| Device Name: | SYSTEMS INTEGRATION MODEL: ENDOALPHA |
| Classification | Endoscopic Central Control Unit |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION REGULATORY AFFAIRS & QUALITY 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
| Contact | Stacy Kluesner |
| Correspondent | Stacy Kluesner OLYMPUS MEDICAL SYSTEMS CORPORATION REGULATORY AFFAIRS & QUALITY 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
| Product Code | ODA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-05 |
| Decision Date | 2010-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170291593 | K100345 | 000 |
| 04953170291517 | K100345 | 000 |
| 04953170291494 | K100345 | 000 |
| 04953170291470 | K100345 | 000 |
| 04953170286117 | K100345 | 000 |
| 04953170286049 | K100345 | 000 |
| 04953170286032 | K100345 | 000 |
| 04953170026386 | K100345 | 000 |
| 04953170148040 | K100345 | 000 |