Propaq Encore 200 Series Monitor with Neonatal Mode and Impedance Pneumography Options
FDA 510(k) K951246 · Protocol Systems, Inc.
510(k) numberK951246
Submission
- Device name
- Propaq Encore 200 Series Monitor with Neonatal Mode and Impedance Pneumography Options
- Applicant
- Protocol Systems, Inc.
Beaverton, OR, US - Received
- March 20, 1995
- Decision date
- February 2, 1996
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- Type
- Traditional 510(k)
Device classification
- Product code
- FLS – Monitor, Apnea, Facility Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2377
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K962865 | Rembrandt SystemFLS · Traditional | Airsep Corp. | 10/25/1996ST |
| K894973 | Respitrace PlusFLS · Traditional | Hogan & Hartson | 10/30/1989SE |
| K832999 | Respiration MonitorFLS · Traditional | Litton Medical Electronics | 02/13/1984SE |
| K830778 | Monitoring Kit AMK-1FLS · Traditional | Alternative Design Systems, Inc. | 10/14/1983SE |
| K822077 | Respiration Monitor Type MR-10FLS · Traditional | New Dimensions IN Medicine, Inc. | 10/06/1982SE |
| K821721 | Clinical Data Apnea DetectorFLS · Traditional | Clinical Data, Inc. | 07/13/1982SE |
| K820943 | System I Infant Monitoring SysFLS · Traditional | Burr Engineering & Development Co. | 05/03/1982SE |
| K810153 | Ventilatory Effort MonitorFLS · Traditional | Medicon, Inc. | 02/09/1981SE |
More from Medicon, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K002725 | Micropaq, Models 402 and 404DRT · Traditional | 11/21/2000SE |
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| K945071 | Propaq 200 MonitorDRT · Traditional | 05/10/1995SE |
| K935846 | Model Acuity Central StationDSI · Traditional | 12/05/1994SE |
| K934711 | Propaq ECG Telemetry OptionDRG · Traditional | 09/01/1994SE |
| K921497 | Propaq Monitors, ModificationCCK · Traditional | 03/23/1993SE |
| K914838 | Propaq 102,104,106,102EL,104EL,&106ELMHX · Traditional | 01/10/1992SE |
| K913193 | Model 100 Central StationDQK · Traditional | 10/16/1991SE |
| K910882 | Propaq 102EL, 104EL and 106ELDRT · Traditional | 05/08/1991SE |
| K910772 | Propaq 102, 104 and 106DXN · Traditional | 04/12/1991SE |
Questions and answers
When was Propaq Encore 200 Series Monitor with Neonatal Mode and Impedance Pneumography Options cleared by the FDA?
Propaq Encore 200 Series Monitor with Neonatal Mode and Impedance Pneumography Options (K951246) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on February 2, 1996, 319 days after the submission was received.
What is the product code of K951246?
The FDA product code is FLS – Monitor, Apnea, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.2377.