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FDA 510(k)

ARTEOIAL TONOMETER ML-105

K-Number: K771449 · 1977-09-06

ApplicantNicolet Biomedical Instruments
Decision Date1977-09-06
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARTEOIAL TONOMETER ML-105 is the device name listed in this FDA 510(k) record. The listed applicant is Nicolet Biomedical Instruments. It received FDA 510(k) clearance on 1977-09-06 under 510(k) number K771449. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTEOIAL TONOMETER ML-105?

ARTEOIAL TONOMETER ML-105 is a medical device that received FDA 510(k) clearance on 1977-09-06. The listed applicant is Nicolet Biomedical Instruments. The 510(k) number is K771449.

When did ARTEOIAL TONOMETER ML-105 receive FDA 510(k) clearance?

ARTEOIAL TONOMETER ML-105 received FDA 510(k) clearance on 1977-09-06, under 510(k) number K771449.

Who is the listed applicant for ARTEOIAL TONOMETER ML-105?

The FDA 510(k) record lists Nicolet Biomedical Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARTEOIAL TONOMETER ML-105?

The FDA product code for ARTEOIAL TONOMETER ML-105 is DXN.

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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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