FDA 510(k)

ELECYS CALCHECK T 3

K-Number: K963167 · 1996-08-27

Decision Date1996-08-27

Product CodeJJX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ELECYS CALCHECK T 3 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 1996-08-27 under 510(k) number K963167. 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 ELECYS CALCHECK T 3?

ELECYS CALCHECK T 3 is a medical device that received FDA 510(k) clearance on 1996-08-27. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K963167.

When did ELECYS CALCHECK T 3 receive FDA 510(k) clearance?

ELECYS CALCHECK T 3 received FDA 510(k) clearance on 1996-08-27, under 510(k) number K963167.

Who is the listed applicant for ELECYS CALCHECK T 3?

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 ELECYS CALCHECK T 3?

The FDA product code for ELECYS CALCHECK T 3 is JJX.

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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.