Precision Gas Mixer
FDA 510(k) K781417 · Medicor USA , Ltd.
510(k) numberK781417
Submission
- Device name
- Precision Gas Mixer
- Applicant
- Medicor USA , Ltd.
Mchenry, IL, US - Received
- August 16, 1978
- Decision date
- September 20, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LCH – Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
Other 510(k)s with product code LCH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K922386 | RNA Medical TonometerLCH · Traditional | Bionostics, Inc. | 06/26/1992SE |
| K904163 | Clinical Blood Gas MixturesLCH · Traditional | Norco, Inc. | 11/01/1990SE |
| K900819 | Blood Gas Calibration StandardLCH · Traditional | Cryogenic Rare Gas Laboratories, Inc. | 04/25/1990SE |
| K862958 | Amr Research TonometerLCH · Traditional | Associated Medical Representatives | 11/24/1986SE |
| K841089 | Linear Cloud TonometerLCH · Traditional | Linear Tonometers, Inc. | 05/22/1984SE |
| K802379 | Hem-O-Scan Oxygen Equil. Curve AnalyzerLCH · Traditional | American Instrument Co. | 10/31/1980SE |
| K801599 | Corning 184 Blood Gas TonometerLCH · Traditional | Corning Medical & Scientific | 08/20/1980SE |
| K781386 | Ebs 775 TonometerLCH · Traditional | Equilibrated Bio Systems, Inc. | 09/14/1978SE |
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| 510(k) | Device | Decision |
|---|---|---|
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| K860025 | Model MS-325 Radiographic X-Ray GeneratorKPR · Traditional | 05/07/1986SE |
| K850761 | Model Pcx/Emy 525A Microprocesssor Control X-Ray CBZN · Traditional | 09/19/1985SE |
| K851358 | Model Bion 2/TYPE 90 Room IonizerFRF · Traditional | 07/01/1985SE |
| K851094 | Model Bion 1/TYPE 1084T Car IonizerFRF · Traditional | 06/19/1985SE |
| K843335 | Floor Mounted X-Ray TubestandIYB · Traditional | 11/27/1984SE |
| K840227 | UROLIX-3 Urological TableIXR · Traditional | 03/23/1984SE |
| K840225 | C-Arm Ceiling Crane FT-2JAA · Traditional | 03/22/1984SE |
| K840226 | Motor Tilted Exam. Table UV-56IXR · Traditional | 03/16/1984SE |
Questions and answers
When was Precision Gas Mixer cleared by the FDA?
Precision Gas Mixer (K781417) received a 510(k) decision of Substantially Equivalent on September 20, 1978, 35 days after the submission was received.
What is the product code of K781417?
The FDA product code is LCH – Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical, a Class I (low risk) device regulated under 21 CFR 862.1660.