510(k) K854076
- Device
- Mga 2000 Gas Analyser
- Applicant
- AIRSPEC LTD.
- 510(k) number
- K854076
- Product code
- DOP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-12-11
- Date received
- 1985-10-07
- Regulation
- 862.2860
- Classification name
- Mass Spectrometer, Clinical Use
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CRAWFORD
- Address
- Airport Industrial Estate Biggin Hill Westerham Kent #16 Tn 16 3bw, England GB
FDA Registration Numbers#
- 3003809634
- 2916205
- 3043088937
- 3008336863
- 9610126
- 3009715051
- 3010607747
- 9614673
- 3009189893
- 3043138885
- 1218959
- 3000221947
- 3007386004
- 3001040364
- 9616673
- 8043909
- 3010962166
- 3003423869
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DOP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K992163 | ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS | Pdz-Europa , Ltd. | 1999-07-13 |
| K974322 | ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM | Europa Scientific, Ltd. | 1997-12-16 |
| K880418 | INCOS 50 MASS SPECTROMETER | Finnigan Corp. | 1988-05-31 |
| K880090 | ION TRAP DETECTOR | Finnigan Corp. | 1988-03-15 |
| K880089 | FINNIGAN MAT TSQ-70 | Finnigan Corp. | 1988-02-11 |
| K872464 | ION TRAP DETECTOR (ITD) | The Perkin-Elmer Corp. | 1987-08-11 |
| K810938 | MASS SPECTROMETER-MEDSPECT II | Allied Healthcare Products, Inc. | 1981-04-23 |
| K770994 | FURNACE AUTOSAMPLER, MODEL 155 | Instrumentation Laboratory CO | 1977-08-22 |
| K770637 | MERCURY/HYDRIDE SYSTEM MHS-1 | The Perkin-Elmer Corp. | 1977-06-23 |