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FDA 510(k)

FIRST MEDIC PULSE OXIMETRY MODULE

K-Number: K955890 · 1997-07-28

ApplicantColorado Medtech, Inc.
Decision Date1997-07-28
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FIRST MEDIC PULSE OXIMETRY MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Colorado Medtech, Inc.. It received FDA 510(k) clearance on 1997-07-28 under 510(k) number K955890. The device is classified under product code MKJ. It was reviewed by the CV advisory panel. Product code MKJ falls under the category of Dental, which includes dental instruments, materials, and equipment. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIRST MEDIC PULSE OXIMETRY MODULE?

FIRST MEDIC PULSE OXIMETRY MODULE is a medical device that received FDA 510(k) clearance on 1997-07-28. The listed applicant is Colorado Medtech, Inc.. The 510(k) number is K955890.

When did FIRST MEDIC PULSE OXIMETRY MODULE receive FDA 510(k) clearance?

FIRST MEDIC PULSE OXIMETRY MODULE received FDA 510(k) clearance on 1997-07-28, under 510(k) number K955890.

Who is the listed applicant for FIRST MEDIC PULSE OXIMETRY MODULE?

The FDA 510(k) record lists Colorado Medtech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIRST MEDIC PULSE OXIMETRY MODULE?

The FDA product code for FIRST MEDIC PULSE OXIMETRY MODULE is MKJ. This falls under the Dental category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Colorado Medtech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K981047FRESH AIR

Related Devices (Code: MKJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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