Balloon for Ultrasonic Endoscopes

FDA 510(k) K992178 · N.M. Beale Co., Inc.

Substantially Equivalent

510(k) numberK992178

Submission

Device name
Balloon for Ultrasonic Endoscopes
Applicant
N.M. Beale Co., Inc.
Harvard, MA, US
Received
June 28, 1999
Decision date
May 12, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
ITX – Transducer, Ultrasonic, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1570
Specialty
Radiology

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Questions and answers

When was Balloon for Ultrasonic Endoscopes cleared by the FDA?

Balloon for Ultrasonic Endoscopes (K992178) received a 510(k) decision of Substantially Equivalent on May 12, 2000, 319 days after the submission was received.

What is the product code of K992178?

The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.