Lifesigns Receiving Cener 2000 Transtelephonic Receiver
FDA 510(k) K951096 · Instromedix, Inc.
510(k) numberK951096
Submission
- Device name
- Lifesigns Receiving Cener 2000 Transtelephonic Receiver
- Applicant
- Instromedix, Inc.
Hillsboro, OR, US - Received
- March 7, 1995
- Decision date
- January 16, 1996
- 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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|---|---|---|---|
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| K250258 | HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemDXH · Traditional | Heartbeam, Inc. | 12/08/2025SE |
| K243438 | MEMO Patch M (MPT-E08R-UNC01)DXH · Traditional | Huinno Co., Ltd. | 12/05/2025SE |
| K243981 | Hexoskin Medical System (7100-00016)DXH · Traditional | Carre Technologies, Inc. | 11/18/2025SE |
| K243003 | VitalSigns 1-Lead Holter (VSH101)DXH · Traditional | VitalSigns Technology Co., Ltd. | 06/17/2025SE |
| K233521 | QT ECG (QTERD100)DXH · Special | QT Medical, Inc. | 12/06/2023SE |
| K222842 | V-Patch Cardiac MonitorDXH · Traditional | Shandong Corecare Technology Limited | 10/20/2022SE |
| K220795 | QT ECGDXH · Traditional | QT Medical, Inc. | 09/26/2022SE |
| K213357 | Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse MonitorDXH · Traditional | Verily Life Sciences, LLC | 07/19/2022SE |
| K220350 | KardiaMobile 6LDXH · Traditional | AliveCor, Inc. | 05/25/2022SE |
More from AliveCor, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K010945 | Heartcard, Model 5258DXH · Traditional | 06/12/2001SE |
| K964408 | Poseidon Cardiac Monitoring System (PCMS)DPS · Traditional | 07/23/1997SE |
| K964036 | Cardiomagic 2000 SoftwareDXH · Traditional | 07/18/1997SE |
| K955060 | Accelerated Transmission ProtocolDXH · Traditional | 04/08/1996SE |
| K945476 | Hearthwatch Iii(Tm)DXH · Traditional | 11/09/1995SE |
| K950003 | Cardiomagic(R) Software EnhancementsDXH · Traditional | 10/31/1995SE |
| K944362 | Heartcard Cardiac Event MonitorDXH · Traditional | 09/07/1995SE |
| K943931 | Carryall EnhancementsDXH · Traditional | 04/04/1995SE |
| K935586 | PrinceDXH · Traditional | 11/08/1994SE |
| K925639 | Cardiomagic SoftwareDXH · Traditional | 06/22/1993SE |
Questions and answers
When was Lifesigns Receiving Cener 2000 Transtelephonic Receiver cleared by the FDA?
Lifesigns Receiving Cener 2000 Transtelephonic Receiver (K951096) received a 510(k) decision of Substantially Equivalent on January 16, 1996, 315 days after the submission was received.
What is the product code of K951096?
The FDA product code is DXH – Transmitters And Receivers, Electrocardiograph, Telephone, a Class II (moderate risk) device regulated under 21 CFR 870.2920.