Pagewriter 10/10I, Model M2662A Handheld Electrocardiograph
FDA 510(k) K002459 · Agilent Technologies, Inc.
510(k) numberK002459
Submission
- Device name
- Pagewriter 10/10I, Model M2662A Handheld Electrocardiograph
- Applicant
- Agilent Technologies, Inc.
Andover, MA, US - Received
- August 10, 2000
- Decision date
- November 8, 2000
- 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 |
|---|---|---|
| K163367 | GenetiSure Dx Postnatal AssayPFX · Traditional | 08/11/2017SE |
| K010949 | 2010 Plus Holter for WindowsMLO · Traditional | 09/28/2001SE |
| K012094 | Modification to Device Link System, Model M2376AMWI · Special | 07/20/2001SE |
| K011824 | Agilent M2636B Telemon B Monitor (Telemon B)DSI · Special | 07/02/2001SE |
| K010634 | Heartstream XL Defibibrillator/Monitor, Model M4735A, Heartstream XLT…MKJ · Traditional | 06/11/2001SE |
| K011578 | M2376A Devicelink System, Model M2376AMWI · Special | 06/08/2001SE |
| K003819 | Heartstream Attenuated Defibrillation Pads, Model M3870AMKJ · Traditional | 05/02/2001SE |
| K011093 | Agilent Information Center Software for M3150,M3151,M3153 and M3154MHX · Special | 05/01/2001SE |
| K010453 | M2376A Devicelink SystemMWI · Special | 03/02/2001SE |
| K010342 | M2376A Devicelink System, Model M2376AMWI · Special | 02/14/2001SE |
Questions and answers
When was Pagewriter 10/10I, Model M2662A Handheld Electrocardiograph cleared by the FDA?
Pagewriter 10/10I, Model M2662A Handheld Electrocardiograph (K002459) received a 510(k) decision of Substantially Equivalent on November 8, 2000, 90 days after the submission was received.
What is the product code of K002459?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.