Ebs 775 Tonometer
FDA 510(k) K781386 · Equilibrated Bio Systems, Inc.
510(k) numberK781386
Submission
- Device name
- Ebs 775 Tonometer
- Applicant
- Equilibrated Bio Systems, Inc.
Mchenry, IL, US - Received
- August 11, 1978
- Decision date
- September 14, 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 |
| K781417 | Precision Gas MixerLCH · Traditional | Medicor USA , Ltd. | 09/20/1978SE |
More from Medicor USA , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K892705 | EBS2605 Infant HuggerBTY · Traditional | 10/27/1989SE |
| K855102 | Monark 869 ErgometerDSP · Traditional | 05/09/1986SE |
| K843996 | Turboaire Challanger Environmental Air ControllerBZG · Traditional | 11/20/1984SE |
| K791294 | SpirocalBXX · Traditional | 08/16/1979SE |
| K790410 | Adult Zee-FrameJAY · Traditional | 03/22/1979SE |
| K781509 | Zee-FrameJAY · Traditional | 09/26/1978SE |
Questions and answers
When was Ebs 775 Tonometer cleared by the FDA?
Ebs 775 Tonometer (K781386) received a 510(k) decision of Substantially Equivalent on September 14, 1978, 34 days after the submission was received.
What is the product code of K781386?
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.