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FDA 510(k)

STATPAL BLOOD GAS MONITORING SYSTEM

K-Number: K903965 · 1990-12-26

ApplicantPpg Industries, Inc.
Decision Date1990-12-26
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STATPAL BLOOD GAS MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ppg Industries, Inc.. It received FDA 510(k) clearance on 1990-12-26 under 510(k) number K903965. 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 STATPAL BLOOD GAS MONITORING SYSTEM?

STATPAL BLOOD GAS MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1990-12-26. The listed applicant is Ppg Industries, Inc.. The 510(k) number is K903965.

When did STATPAL BLOOD GAS MONITORING SYSTEM receive FDA 510(k) clearance?

STATPAL BLOOD GAS MONITORING SYSTEM received FDA 510(k) clearance on 1990-12-26, under 510(k) number K903965.

Who is the listed applicant for STATPAL BLOOD GAS MONITORING SYSTEM?

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

What is the FDA product code for STATPAL BLOOD GAS MONITORING SYSTEM?

The FDA product code for STATPAL BLOOD GAS MONITORING SYSTEM is CHL.

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Other records listing Ppg Industries, 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.

K922631STATPAL II BLOOD GAS ANALYSIS SYSTEMK913358MIDAS SYSTEM(TM) 5100 PHYSIOLOG MONIT/RECORD SYSTK914560STAT PAL SENSYR SYRINGE ASSEMBLY FOR USE W/STATPALK912627MIDAS SYSTEM 2500, PHYSIOLOGICAL MONITORING SYSTEMK901514XR MODEL H PHYSIOLOGICAL MONITOR & RECORDING SYS.K900246CARDIOTEST EK 53 R, CARDIOGNOST EK 56/ EK 512

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Related Devices (Code: CHL)

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.

K252207ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals ApsK244014i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K240998ABL90 FLEX PLUS SystemRadiometer Medicals ApsK230285i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K221900Stat Profile Prime Plus Analyzer SystemNova Biomedical CorporationK223857i-STAT G3+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.

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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