Modular Mass Spectrometer (M.S.)
FDA 510(k) K862605 · The Perkin-Elmer Corp.
510(k) numberK862605
Submission
- Device name
- Modular Mass Spectrometer (M.S.)
- Applicant
- The Perkin-Elmer Corp.
Pomona, CA, US - Received
- July 8, 1986
- Decision date
- August 13, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1400
- Specialty
- Anesthesiology
Other 510(k)s with product code CCK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251641 | GF-310R Multigas Unit (GF-310R)CCK · Traditional | Nihon Kohden Corporation | 08/12/2026SE |
| K261633 | VisuBreathCCK · Traditional | Affirm Medical Technologies II, LLC | 07/14/2026SE |
| K253030 | Capnostream35 Portable Respiratory Monitor (PM35MN)CCK · Traditional | Covidien, LLC | 05/01/2026SE |
| K250148 | Medical Gas Analyzer (AG200)CCK · Traditional | Prior Care Science Technology, Ltd. | 08/28/2025SE |
| K243956 | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)CCK · Traditional | Nihon Kohden Corporation | 06/10/2025SE |
| K251216 | 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2…CCK · Traditional | Barbaras Development, Inc. | 06/04/2025SE |
| K240937 | Aim (N/A)CCK · Traditional | Inventeur, LLC | 12/16/2024SE |
| K230915 | AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen MaskCCK · Traditional | Vyaire Medical, Inc. | 11/12/2024SE |
| K212425 | MicroTrend SystemCCK · Traditional | Exostat Medical, Inc. | 11/07/2024SE |
| K222511 | Oxy2ProCCK · Traditional | Southmedic, Inc. | 11/21/2023SE |
More from Southmedic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K935666 | Perkin-Elmer Series 200 Liq Chromatographic PumpKIE · Traditional | 04/26/1994SE |
| K900828 | Perkin-Elmer Aa 3100 Atomic Absorption Spectro.JXR · Traditional | 04/09/1990SE |
| K884864 | Plasma 40 Induct. Coupled Plasma Emmission SpectroJJQ · Traditional | 02/10/1989SE |
| K884886 | Model 250 Liquid Chromotagraphy PumpLDM · Traditional | 02/02/1989SE |
| K872737 | Perkin-Elmer LC235 Diode Array Detector · Traditional | 09/18/1987SE |
| K872464 | Ion Trap Detector (Itd)DOP · Traditional | 08/11/1987SE |
| K871550 | PFI-20 Polarizing FluorimeterKHO · Traditional | 07/01/1987SE |
| K872122 | 8000 Series Gas ChromatographsKZQ · Traditional | 06/17/1987SE |
| K870661 | Lifewatch PlusBZQ · Traditional | 03/09/1987SE |
| K862178 | Isopure LC SystemLDM · Traditional | 07/14/1986SE |
Questions and answers
When was Modular Mass Spectrometer (M.S.) cleared by the FDA?
Modular Mass Spectrometer (M.S.) (K862605) received a 510(k) decision of Substantially Equivalent on August 13, 1986, 36 days after the submission was received.
What is the product code of K862605?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.