The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Ultrasonic Probe For Esophogus (mh-908).
Device ID | K952892 |
510k Number | K952892 |
Device Name: | OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908) |
Classification | Transducer, Ultrasonic, Diagnostic |
Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
Contact | Barry E Sands |
Correspondent | Barry E Sands OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
Product Code | ITX |
CFR Regulation Number | 892.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-23 |
Decision Date | 1996-02-12 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04953170360435 | K952892 | 000 |
04953170055553 | K952892 | 000 |
04953170055560 | K952892 | 000 |
04953170055577 | K952892 | 000 |
04953170055591 | K952892 | 000 |
14953170058858 | K952892 | 000 |
04953170064692 | K952892 | 000 |
04953170064883 | K952892 | 000 |
04953170355691 | K952892 | 000 |
04953170355707 | K952892 | 000 |
04953170355745 | K952892 | 000 |
04953170355752 | K952892 | 000 |
04953170356063 | K952892 | 000 |
04953170356186 | K952892 | 000 |
04953170055546 | K952892 | 000 |