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 |