LCH — Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical Class I
FDA product code LCH covers "Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical", a Class I medical device regulated under 21 CFR 862.1660. Submissions are reviewed by the Clinical Chemistry panel. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LCH
- Device Class
- Class I
- Regulation Number
- 862.1660
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K922386 | bionostics | RNA MEDICAL TONOMETER | June 26, 1992 |
| K904163 | norco | CLINICAL BLOOD GAS MIXTURES | November 1, 1990 |
| K900819 | cryogenic rare gas laboratories | BLOOD GAS CALIBRATION STANDARD | April 25, 1990 |
| K862958 | associated medical representatives | AMR RESEARCH TONOMETER | November 24, 1986 |
| K841089 | linear tonometers | LINEAR CLOUD TONOMETER | May 22, 1984 |
| K802379 | american instrument | HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER | October 31, 1980 |
| K801599 | corning medical and scientific | CORNING 184 BLOOD GAS TONOMETER | August 20, 1980 |
| K781417 | medicor usa | PRECISION GAS MIXER | September 20, 1978 |
| K781386 | equilibrated bio systems | EBS 775 TONOMETER | September 14, 1978 |