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FDA 510(k)

UROTRON

K-Number: K781632 · 1978-12-20

ApplicantBoehringer Mannheim Corp.
Decision Date1978-12-20
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UROTRON is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1978-12-20 under 510(k) number K781632. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UROTRON?

UROTRON is a medical device that received FDA 510(k) clearance on 1978-12-20. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K781632.

When did UROTRON receive FDA 510(k) clearance?

UROTRON received FDA 510(k) clearance on 1978-12-20, under 510(k) number K781632.

Who is the listed applicant for UROTRON?

The FDA 510(k) record lists Boehringer Mannheim Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UROTRON?

The FDA product code for UROTRON is JJQ.

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Other records listing Boehringer Mannheim Corp. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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