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FDA 510(k)

OXINET N-7500 PULSE OXIMETRY NETWORK

K-Number: K884142 · 1988-12-16

ApplicantNellcor, Inc.
Decision Date1988-12-16
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OXINET N-7500 PULSE OXIMETRY NETWORK is the device name listed in this FDA 510(k) record. The listed applicant is Nellcor, Inc.. It received FDA 510(k) clearance on 1988-12-16 under 510(k) number K884142. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXINET N-7500 PULSE OXIMETRY NETWORK?

OXINET N-7500 PULSE OXIMETRY NETWORK is a medical device that received FDA 510(k) clearance on 1988-12-16. The listed applicant is Nellcor, Inc.. The 510(k) number is K884142.

When did OXINET N-7500 PULSE OXIMETRY NETWORK receive FDA 510(k) clearance?

OXINET N-7500 PULSE OXIMETRY NETWORK received FDA 510(k) clearance on 1988-12-16, under 510(k) number K884142.

Who is the listed applicant for OXINET N-7500 PULSE OXIMETRY NETWORK?

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

What is the FDA product code for OXINET N-7500 PULSE OXIMETRY NETWORK?

The FDA product code for OXINET N-7500 PULSE OXIMETRY NETWORK is DXH. This falls under the Hematology category.

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Other records listing Nellcor, 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.

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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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