Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246
FDA 510(k) K012451 · Welch Allyn Protocol, Inc.
510(k) numberK012451
Submission
- Device name
- Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246
- Applicant
- Welch Allyn Protocol, Inc.
Beaverton, OR, US - Received
- August 1, 2001
- Decision date
- August 20, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
Other 510(k)s with product code DRT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261286 | The Circadia C300 System (C300)DRT · Special | Circadia Health, Inc. | 05/20/2026SE |
| K252676 | The Circadia C300 System (C300)DRT · Traditional | Circadia Health, Inc. | 02/03/2026SE |
| K253388 | Sleepiz One+ (Model 2.5)DRT · Special | Sleepiz AG | 01/28/2026SE |
| K251364 | Sleepiz One+ (2.5)DRT · Special | Sleepiz AG | 07/29/2025SE |
| K234003 | The Circadia C200 SystemDRT · Traditional | Circadia Technologies, Ltd. | 05/30/2024SE |
| K232354 | Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server…DRT · Traditional | Murata Vios, Inc. | 03/22/2024SE |
| K231733 | Neteera 130H-Plus Vital Sign Monitoring SensorDRT · Traditional | Neteera Technologies , Ltd. | 02/09/2024SE |
| K223163 | Sleepiz One+DRT · Traditional | Sleepiz AG | 08/18/2023SE |
| K212143 | Neteera 130H/131H Vital Sign Monitoring SensorDRT · Traditional | Neteera Technologies , Ltd. | 09/28/2022SE |
| K202138 | Cardiac Trigger MonitorDRT · Traditional | Ivy Biomedical Systems, Inc. | 05/14/2021SE |
More from Ivy Biomedical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K070204 | Link to Acuity Clinician NotifierMSX · Special | 03/23/2007SE |
| K063419 | Modification to Vsm- Vital Signs Monitor, (VSM 300 )MWI · Special | 12/04/2006SE |
| K033378 | Vital Signs Monitor, Propaq LTMWI · Traditional | 03/01/2004SE |
| K031740 | VSM - Vital Signs Monitor, Model 53000 SeriesDQA · Traditional | 08/26/2003SE |
| K022453 | Modification to Acuity Central Monitoring SystemDSI · Special | 08/21/2002SE |
| K021681 | Micropaq, Models 402, 404DRT · Special | 07/23/2002SE |
Questions and answers
When was Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 cleared by the FDA?
Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 (K012451) received a 510(k) decision of Substantially Equivalent on August 20, 2001, 19 days after the submission was received.
What is the product code of K012451?
The FDA product code is DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), a Class II (moderate risk) device regulated under 21 CFR 870.2300.