OLYMPUS UM 2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT, FOR BRONCHIAL USE

Transducer, Ultrasonic, Diagnostic

OLYMPUS AMERICA, INC.

The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Um 2r/3r Ultrasonic Probes And Associated Ancillary Equipment, For Bronchial Use.

Pre-market Notification Details

• Device ID: K982323
• 510k Number: K982323
• Device Name: OLYMPUS UM 2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT, FOR BRONCHIAL USE
• Classification: Transducer, Ultrasonic, Diagnostic
• Applicant: OLYMPUS AMERICA, INC. 2 CORPORATE CENTER DR. Melville, NY 11747 -3157
• Contact: Laura Storms-tyler
• Correspondent: Laura Storms-tyler; OLYMPUS AMERICA, INC. 2 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: 1998-07-02
• Decision Date: 1998-12-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04953170368479	K982323	000
04953170241000	K982323	000