Hem-O-Scan Oxygen Equil. Curve Analyzer
FDA 510(k) K802379 · American Instrument Co.
510(k) numberK802379
Submission
- Device name
- Hem-O-Scan Oxygen Equil. Curve Analyzer
- Applicant
- American Instrument Co.
Mchenry, IL, US - Received
- September 30, 1980
- Decision date
- October 31, 1980
- 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 |
| K801599 | Corning 184 Blood Gas TonometerLCH · Traditional | Corning Medical & Scientific | 08/20/1980SE |
| K781417 | Precision Gas MixerLCH · Traditional | Medicor USA , Ltd. | 09/20/1978SE |
| K781386 | Ebs 775 TonometerLCH · Traditional | Equilibrated Bio Systems, Inc. | 09/14/1978SE |
Questions and answers
When was Hem-O-Scan Oxygen Equil. Curve Analyzer cleared by the FDA?
Hem-O-Scan Oxygen Equil. Curve Analyzer (K802379) received a 510(k) decision of Substantially Equivalent on October 31, 1980, 31 days after the submission was received.
What is the product code of K802379?
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.