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FDA 510(k)

PRECINORM RF, PRECIPATH RF

K-Number: K973629 · 1997-10-07

ApplicantBoehringer Mannheim Corp.
Decision Date1997-10-07
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PRECINORM RF, PRECIPATH RF 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 1997-10-07 under 510(k) number K973629. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECINORM RF, PRECIPATH RF?

PRECINORM RF, PRECIPATH RF is a medical device that received FDA 510(k) clearance on 1997-10-07. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K973629.

When did PRECINORM RF, PRECIPATH RF receive FDA 510(k) clearance?

PRECINORM RF, PRECIPATH RF received FDA 510(k) clearance on 1997-10-07, under 510(k) number K973629.

Who is the listed applicant for PRECINORM RF, PRECIPATH RF?

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 PRECINORM RF, PRECIPATH RF?

The FDA product code for PRECINORM RF, PRECIPATH RF is JJY.

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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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