Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BLOOD GAS CALIBRATION STANDARD

K-Number: K900819 · 1990-04-25

ApplicantCryogenic Rare Gas Laboratories, Inc.
Decision Date1990-04-25
Product CodeLCH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BLOOD GAS CALIBRATION STANDARD is the device name listed in this FDA 510(k) record. The listed applicant is Cryogenic Rare Gas Laboratories, Inc.. It received FDA 510(k) clearance on 1990-04-25 under 510(k) number K900819. The device is classified under product code LCH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOOD GAS CALIBRATION STANDARD?

BLOOD GAS CALIBRATION STANDARD is a medical device that received FDA 510(k) clearance on 1990-04-25. The listed applicant is Cryogenic Rare Gas Laboratories, Inc.. The 510(k) number is K900819.

When did BLOOD GAS CALIBRATION STANDARD receive FDA 510(k) clearance?

BLOOD GAS CALIBRATION STANDARD received FDA 510(k) clearance on 1990-04-25, under 510(k) number K900819.

Who is the listed applicant for BLOOD GAS CALIBRATION STANDARD?

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

What is the FDA product code for BLOOD GAS CALIBRATION STANDARD?

The FDA product code for BLOOD GAS CALIBRATION STANDARD is LCH.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: LCH)

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.

K922386RNA MEDICAL TONOMETERBionostics, Inc.K904163CLINICAL BLOOD GAS MIXTURESNorco, Inc.K862958AMR RESEARCH TONOMETERAssociated Medical RepresentativesK841089LINEAR CLOUD TONOMETERLinear Tonometers, Inc.K802379HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZERAmerican Instrument Co.K801599CORNING 184 BLOOD GAS TONOMETERCorning Medical & Scientific

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.

↑