FDA 510(k)

ELECSYS CALLCHECK DIGOXIN

K-Number: K973973 · 1997-11-04

Decision Date1997-11-04

Product CodeDMP

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

ELECSYS CALLCHECK DIGOXIN 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 1997-11-04 under 510(k) number K973973. The device is classified under product code DMP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECSYS CALLCHECK DIGOXIN?

ELECSYS CALLCHECK DIGOXIN is a medical device that received FDA 510(k) clearance on 1997-11-04. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K973973.

When did ELECSYS CALLCHECK DIGOXIN receive FDA 510(k) clearance?

ELECSYS CALLCHECK DIGOXIN received FDA 510(k) clearance on 1997-11-04, under 510(k) number K973973.

Who is the listed applicant for ELECSYS CALLCHECK DIGOXIN?

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 CALLCHECK DIGOXIN?

The FDA product code for ELECSYS CALLCHECK DIGOXIN is DMP.

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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.