Surveyor S2
FDA 510(k) K182297 · Mortara Instrument, Inc.
510(k) numberK182297
Submission
- Device name
- Surveyor S2
- Applicant
- Mortara Instrument, Inc.
Milwaukee, WI, US - Received
- August 24, 2018
- Decision date
- January 24, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2910
- Specialty
- Cardiovascular
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| K241101 | BioButton SystemDRG · Traditional | Biointellisense, Inc. | 09/26/2024SE |
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| K220526 | HD+12, HD+15DRG · Traditional | Cardioline S.P.A | 05/15/2023SE |
More from Cardioline S.P.A
| 510(k) | Device | Decision |
|---|---|---|
| K173765 | Surveyor Patient MonitorMHX · Traditional | 09/04/2018SE |
| K161517 | Mortara Surveyor Patient MonitorMHX · Traditional | 01/11/2017SE |
| K161465 | CardioConfirmDQK · Traditional | 09/03/2016SE |
| K160685 | Surveyor S4 Mobile MonitorMHX · Traditional | 08/04/2016SE |
| K152626 | H3+ Holter RecorderMWJ · Traditional | 02/26/2016SE |
| K152944 | Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing SystemsDPS · Traditional | 01/06/2016SE |
| K141020 | Surveyor S4 Mobile MonitorDRG · Traditional | 12/03/2014SE |
| K133989 | Ambulo 2400 Ambulatory Blood Pressure Monitoring SystemDXN · Abbreviated | 11/25/2014SE |
| K141811 | Mortara Monitoring Waveform ViewerMHX · Abbreviated | 11/19/2014SE |
| K142105 | Eli 380 ElectrocardiographDPS · Special | 09/05/2014SE |
Questions and answers
When was Surveyor S2 cleared by the FDA?
Surveyor S2 (K182297) received a 510(k) decision of Substantially Equivalent on January 24, 2019, 153 days after the submission was received.
What is the product code of K182297?
The FDA product code is DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 870.2910.