Cardioview Transtelephonic Software
FDA 510(k) K955891 · Micromedical, Inc.
510(k) numberK955891
Submission
- Device name
- Cardioview Transtelephonic Software
- Applicant
- Micromedical, Inc.
Stamford, CT, US - Received
- December 29, 1995
- Decision date
- October 8, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DPS – Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2340
- Specialty
- Cardiovascular
Other 510(k)s with product code DPS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Masimo Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K974352 | Cardioview 3000 SoftwareLOS · Traditional | 09/08/1998SE |
| K974220 | Micromedical 12 Lead Simultaneous CableDPS · Traditional | 08/25/1998SE |
| K974351 | Biolog 3000 ElectrocardiographDPS · Traditional | 04/01/1998SE |
| K970305 | Printer InterfaceDXH · Traditional | 08/15/1997SE |
| K895535 | PaceviewKRE · Traditional | 03/19/1990SE |
| K895534 | BiologDRT · Traditional | 03/19/1990SE |
Questions and answers
When was Cardioview Transtelephonic Software cleared by the FDA?
Cardioview Transtelephonic Software (K955891) received a 510(k) decision of Substantially Equivalent on October 8, 1996, 284 days after the submission was received.
What is the product code of K955891?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.