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FDA 510(k)

UROTRON RL9

K-Number: K850348 · 1985-03-12

ApplicantBoehringer Mannheim Corp.
Decision Date1985-03-12
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UROTRON RL9 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 1985-03-12 under 510(k) number K850348. 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 RL9?

UROTRON RL9 is a medical device that received FDA 510(k) clearance on 1985-03-12. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K850348.

When did UROTRON RL9 receive FDA 510(k) clearance?

UROTRON RL9 received FDA 510(k) clearance on 1985-03-12, under 510(k) number K850348.

Who is the listed applicant for UROTRON RL9?

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 RL9?

The FDA product code for UROTRON RL9 is JJQ.

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Other records listing Boehringer Mannheim Corp. as applicant

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Related Devices (Code: JJQ)

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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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