Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical
A clinical tonometer used for calibration and quality control of blood-gas instruments is a device that introduces precisely controlled gas mixtures into blood-gas analyzers to verify their accuracy and calibration, ensuring reliable measurement of blood oxygen, carbon dioxide, and pH. It is classified as FDA Class 1, requiring only general controls with no premarket notification needed. The product code is LCH, regulated under 21 CFR 862.1660, in the Clinical Chemistry specialty. No special risk flags apply.
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Basic Information
- Product Code
- LCH
- Device Class
- FDA class 1
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K922386 | RNA MEDICAL TONOMETER | Jun 26, 1992 | Substantially Equivalent | Bionostics, Inc. |
| K904163 | CLINICAL BLOOD GAS MIXTURES | Nov 01, 1990 | Substantially Equivalent | Norco, Inc. |
| K900819 | BLOOD GAS CALIBRATION STANDARD | Apr 25, 1990 | Substantially Equivalent | Cryogenic Rare Gas Laboratories, Inc. |
| K862958 | AMR RESEARCH TONOMETER | Nov 24, 1986 | Substantially Equivalent | Associated Medical Representatives |
| K841089 | LINEAR CLOUD TONOMETER | May 22, 1984 | Substantially Equivalent | Linear Tonometers, Inc. |
| K802379 | HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER | Oct 31, 1980 | Substantially Equivalent | American Instrument Co. |
| K801599 | CORNING 184 BLOOD GAS TONOMETER | Aug 20, 1980 | Substantially Equivalent | Corning Medical & Scientific |
| K781417 | PRECISION GAS MIXER | Sep 20, 1978 | Substantially Equivalent | Medicor USA , Ltd. |
| K781386 | EBS 775 TONOMETER | Sep 14, 1978 | Substantially Equivalent | Equilibrated Bio Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.