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FDA 510(k)

NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM

K-Number: K982928 · 1999-01-06

ApplicantRadiometer America, Inc.
Decision Date1999-01-06
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer America, Inc.. It received FDA 510(k) clearance on 1999-01-06 under 510(k) number K982928. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM?

NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM is a medical device that received FDA 510(k) clearance on 1999-01-06. The listed applicant is Radiometer America, Inc.. The 510(k) number is K982928.

When did NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM receive FDA 510(k) clearance?

NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM received FDA 510(k) clearance on 1999-01-06, under 510(k) number K982928.

Who is the listed applicant for NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM?

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

What is the FDA product code for NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM?

The FDA product code for NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM is CHL.

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Other records listing Radiometer America, 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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Related Devices (Code: CHL)

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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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