Mass Spectrometer-Medspect II
FDA 510(k) K810938 · Allied Healthcare Products, Inc.
510(k) numberK810938
Submission
- Device name
- Mass Spectrometer-Medspect II
- Applicant
- Allied Healthcare Products, Inc.
Walker, MI, US - Received
- April 7, 1981
- Decision date
- April 23, 1981
- 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 |
| K854076 | Mga 2000 Gas AnalyserDOP · Traditional | Airspec , Ltd. | 12/11/1985SE |
| 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 |
More from The Perkin-Elmer Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K131098 | Emergency Portable VentilatorBTL · Traditional | 04/09/2014SE |
| K132021 | Ahp 300, Emergency Portable VentilatorBTL · Traditional | 04/02/2014SE |
| K090356 | Emergency Portable Ventilator, Model EPV200BTL · Traditional | 05/20/2009SE |
| K083507 | Battery Pack for MCV100 and MCV200 Emergency VentilatorsBTL · Traditional | 05/18/2009SE |
| K083385 | Mass Casualty Ventilators, Models: MCV200 and MCV200-BBTL · Traditional | 05/14/2009SE |
| K080063 | Mass Casualty Ventilator, Model MCV100BTL · Traditional | 08/15/2008SE |
| K072214 | Portable Ventilator, Model EPV-100BTL · Traditional | 03/06/2008SE |
| K073171 | Resuscitation Timer, Model L770-CPRBTM · Traditional | 01/31/2008SE |
| K070636 | Autovent 4000 with CPAPBTL · Traditional | 07/13/2007SE |
| K070120 | Autovent Model 4000BTL · Traditional | 05/03/2007SE |
Questions and answers
When was Mass Spectrometer-Medspect II cleared by the FDA?
Mass Spectrometer-Medspect II (K810938) received a 510(k) decision of Substantially Equivalent on April 23, 1981, 16 days after the submission was received.
What is the product code of K810938?
The FDA product code is DOP – Mass Spectrometer, Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2860.