FDA 510(k)

ELECSYS CALCHECK T UPDATE

K-Number: K963181 · 1996-09-10

Decision Date1996-09-10

Product CodeJJX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ELECSYS CALCHECK T UPDATE 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 1996-09-10 under 510(k) number K963181. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECSYS CALCHECK T UPDATE?

ELECSYS CALCHECK T UPDATE is a medical device that received FDA 510(k) clearance on 1996-09-10. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K963181.

When did ELECSYS CALCHECK T UPDATE receive FDA 510(k) clearance?

ELECSYS CALCHECK T UPDATE received FDA 510(k) clearance on 1996-09-10, under 510(k) number K963181.

Who is the listed applicant for ELECSYS CALCHECK T UPDATE?

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 ELECSYS CALCHECK T UPDATE?

The FDA product code for ELECSYS CALCHECK T UPDATE is JJX.

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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.