Mga 2000 Gas Analyser
FDA 510(k) K854076 · Airspec , Ltd.
510(k) numberK854076
Submission
- Device name
- Mga 2000 Gas Analyser
- Applicant
- Airspec , Ltd.
Tn 16 3bw, England, GB - Received
- October 7, 1985
- Decision date
- December 11, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DOP – Mass Spectrometer, Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2860
- Specialty
- Clinical Chemistry
Other 510(k)s with product code DOP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K992163 | Abca Gas Isotope Ratio Mass Spectrometer SystemsDOP · Special | Pdz-Europa , Ltd. | 07/13/1999SE |
| K974322 | Abca-Nt Gas Isotope Ratio Mass Spectrometer SystemDOP · Traditional | Europa Scientific, Ltd. | 12/16/1997SE |
| K880418 | Incos 50 Mass SpectrometerDOP · Traditional | Finnigan Corp. | 05/31/1988SE |
| K880090 | Ion Trap DetectorDOP · Traditional | Finnigan Corp. | 03/15/1988SE |
| K880089 | Finnigan Mat TSQ-70DOP · Traditional | Finnigan Corp. | 02/11/1988SE |
| K872464 | Ion Trap Detector (Itd)DOP · Traditional | The Perkin-Elmer Corp. | 08/11/1987SE |
| K810938 | Mass Spectrometer-Medspect IIDOP · Traditional | Allied Healthcare Products, Inc. | 04/23/1981SE |
| K770994 | Furnace Autosampler, Model 155DOP · Traditional | Instrumentation Laboratory CO | 08/22/1977SE |
| K770637 | Mercury/Hydride System MHS-1DOP · Traditional | The Perkin-Elmer Corp. | 06/23/1977SE |
Questions and answers
When was Mga 2000 Gas Analyser cleared by the FDA?
Mga 2000 Gas Analyser (K854076) received a 510(k) decision of Substantially Equivalent on December 11, 1985, 65 days after the submission was received.
What is the product code of K854076?
The FDA product code is DOP – Mass Spectrometer, Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2860.