Paceart Cardiophone
FDA 510(k) K931296 · Paceart, Inc.
510(k) numberK931296
Submission
- Device name
- Paceart Cardiophone
- Applicant
- Paceart, Inc.
Wayne, NJ, US - Received
- March 30, 1993
- Decision date
- October 1, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXH – Transmitters And Receivers, Electrocardiograph, Telephone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2920
- Specialty
- Cardiovascular
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More from AliveCor, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K012407 | Paceart TX3 Cardiac Event RecorderDXH · Special | 08/14/2001SE |
| K982090 | Paceart Home Trak Plus Easi Event Recorder SystemDXH · Traditional | 01/26/1999SE |
| K973141 | Heart Access Plus Cardiac Event RecorderDXH · Traditional | 11/12/1997SE |
| K960721 | Paceart Wrist ElectrodesDRX · Traditional | 07/18/1996SE |
| K952065 | Paceart CardiovoiceDXH · Traditional | 01/16/1996SE |
| K915632 | Paceart CPTS-86/12KRE · Traditional | 04/14/1992SE |
| K880283 | Paceart Pacemaker Patient Test Syst/Tel Opt CPTSDXH · Traditional | 03/09/1988SE |
| K870909 | Pacemaker Function AnalyzerKRE · Traditional | 04/27/1987SE |
Questions and answers
When was Paceart Cardiophone cleared by the FDA?
Paceart Cardiophone (K931296) received a 510(k) decision of Substantially Equivalent on October 1, 1993, 185 days after the submission was received.
What is the product code of K931296?
The FDA product code is DXH – Transmitters And Receivers, Electrocardiograph, Telephone, a Class II (moderate risk) device regulated under 21 CFR 870.2920.