The following data is part of a premarket notification filed by The Olympus Optical Co. with the FDA for Olympus Mh-246r Balloon Sheath, For Bronchial Use.
Device ID | K982733 |
510k Number | K982733 |
Device Name: | OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE |
Classification | Transducer, Ultrasonic, Diagnostic |
Applicant | THE OLYMPUS OPTICAL CO. TWO CORPORATE DR. Melville, NY 11747 |
Contact | Laura Storms-taylor |
Correspondent | Laura Storms-taylor THE OLYMPUS OPTICAL CO. TWO CORPORATE DR. Melville, NY 11747 |
Product Code | ITX |
CFR Regulation Number | 892.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-08-05 |
Decision Date | 1998-10-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04953170365157 | K982733 | 000 |
04953170061882 | K982733 | 000 |