Ecscope 100
FDA 510(k) K091358 · Dyansys, Inc.
510(k) numberK091358
Submission
- Device name
- Ecscope 100
- Applicant
- Dyansys, Inc.
Burlingame, CA, US - Received
- May 8, 2009
- Decision date
- May 28, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DPS – Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2340
- Specialty
- Cardiovascular
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|---|---|---|---|
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)DPS · Traditional | Edan Instruments, Inc. | 07/02/2026SE |
| K251670 | MAC 7 Resting ECG Analysis SystemDPS · Traditional | Ge Medical Systems Information Technologies, Inc. | 01/26/2026SE |
| K252361 | AccurECG Analysis System (v2.0)DPS · Traditional | Accurkardia, Inc. | 12/22/2025SE |
| K252474 | Withings BeamO (SCT02)DPS · Traditional | Withings | 11/10/2025SE |
| K250569 | Cardiologs Holter PlatformDPS · Traditional | Philips France Commercial | 08/06/2025SE |
| K243252 | ZBPro DiagnosticDPS · Traditional | Zbeats, Inc. | 07/10/2025SE |
| K243305 | Masimo W1DPS · Traditional | Masimo Corporation | 04/03/2025SE |
| K241217 | CloudHRV System (100-01-001)DPS · Traditional | Inmedix, Inc. | 01/16/2025SE |
| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000)DPS · Traditional | Philips Medizin Systeme Böblingen GmbH | 12/17/2024SE |
| K240229 | Masimo W1DPS · Traditional | Masimo Corporation | 08/08/2024SE |
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| K220397 | ANSiStim-PPNHI · Traditional | 05/12/2022SE |
| K213188 | Primary ReliefNHI · Traditional | 01/31/2022SE |
| K212859 | First ReliefNHI · Traditional | 12/20/2021SE |
| K211971 | Drug Relief v1PZR · Traditional | 11/05/2021SE |
| K202940 | First Relief v1QHH · Traditional | 12/29/2020SE |
| K173861 | Drug ReliefPZR · Traditional | 05/02/2018SE |
| K170391 | ANSiStim-PPBWK · Special | 03/09/2017SE |
| K141168 | AnsistimBWK · Traditional | 05/15/2015SE |
Questions and answers
When was Ecscope 100 cleared by the FDA?
Ecscope 100 (K091358) received a 510(k) decision of Substantially Equivalent on May 28, 2009, 20 days after the submission was received.
What is the product code of K091358?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.