The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Automated Endoscope Leak Tester.
| Device ID | K123704 |
| 510k Number | K123704 |
| Device Name: | AUTOMATED ENDOSCOPE LEAK TESTER |
| Classification | Endoscopic Leak Tester |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORP. REGULATORY AFFAIRS & QUALITY ASSURANCE 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
| Contact | Daphney Germain-kolawole |
| Correspondent | Daphney Germain-kolawole OLYMPUS MEDICAL SYSTEMS CORP. REGULATORY AFFAIRS & QUALITY ASSURANCE 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
| Product Code | PCV |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-03 |
| Decision Date | 2013-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170351792 | K123704 | 000 |
| 04953170351785 | K123704 | 000 |
| 04953170351778 | K123704 | 000 |
| 04953170351761 | K123704 | 000 |
| 04953170415180 | K123704 | 000 |