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FDA 510(k)

BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER

K-Number: K953239 · 1995-09-25

ApplicantBoehringer Mannheim Corp.
Decision Date1995-09-25
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER 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 1995-09-25 under 510(k) number K953239. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER?

BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER is a medical device that received FDA 510(k) clearance on 1995-09-25. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K953239.

When did BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER receive FDA 510(k) clearance?

BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER received FDA 510(k) clearance on 1995-09-25, under 510(k) number K953239.

Who is the listed applicant for BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER?

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 BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER?

The FDA product code for BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER is JJE.

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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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