Stress System, 3-CHANNEL (#21127A)
FDA 510(k) K760465 · Hewlett-Packard Co.
510(k) numberK760465
Submission
- Device name
- Stress System, 3-CHANNEL (#21127A)
- Applicant
- Hewlett-Packard Co.
Mchenry, IL, US - Received
- August 18, 1976
- Decision date
- August 30, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
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| K993383 | HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor Models M3000A…DSI · Abbreviated | 02/03/2000SE |
| K992273 | HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor…MHX · Abbreviated | 01/28/2000SE |
| K993587 | HP M2376A Device Link SystemMQS · Traditional | 01/20/2000SE |
| K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810ADRG · Traditional | 12/20/1999SE |
| K992595 | HP Viridia Component Monitoring System, Model Rev. K with Easi-St Segment Measurement…MHX · Special | 12/08/1999SE |
| K992977 | Hewlett Packard Multifunction Pediatric Defib Function, Model M3503A & M3504AMKJ · Traditional | 12/01/1999SE |
| K993516 | HP M2600A Viridia Telemetry SystemDSI · Special | 11/08/1999SE |
| K992674 | HP Viridia CMS Patient Monitor with EEG Parameter, Model M1027AMHX · Abbreviated | 11/08/1999SE |
| K993171 | HP Viridia Information System, Models M3150A/ M3151A/ M3153A/ M3154ADSI · Special | 10/21/1999SE |
Questions and answers
When was Stress System, 3-CHANNEL (#21127A) cleared by the FDA?
Stress System, 3-CHANNEL (#21127A) (K760465) received a 510(k) decision of Substantially Equivalent on August 30, 1976, 12 days after the submission was received.
What is the product code of K760465?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.