Model {M-102 I-Channel Electro Cardiograph Unit
FDA 510(k) K843934 · Future Impex Corp.
510(k) numberK843934
Submission
- Device name
- Model {M-102 I-Channel Electro Cardiograph Unit
- Applicant
- Future Impex Corp.
Deerpark, NY, US - Received
- October 9, 1984
- Decision date
- November 20, 1984
- 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 |
More from Masimo Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K861487 | ST-90 Spiro AnalizerBTY · Traditional | 06/23/1986SE |
| K854687 | Erma Hb-Meter Model 303NKHG · Traditional | 06/04/1986SE |
| K854686 | TE-25 Coaguro MeterJBP · Traditional | 06/04/1986SE |
| K854685 | DIGITAL-9 Key Leucocyte CounterGKM · Traditional | 04/04/1986SE |
| K854678 | Erma PC-602 PC-603 Blood Cell CounterGKL · Traditional | 02/24/1986SE |
| K854677 | Erma PC-604 Blood Cell CounterGKL · Traditional | 02/24/1986SE |
| K854679 | PHOTIC-100 SpectrophotometerJJQ · Traditional | 02/20/1986SE |
| K843984 | PM-80 PulmotesterBZG · Traditional | 10/24/1984SE |
| K843700 | ST-200A W/Maximal Voluntary Ventillat- · Traditional | 10/24/1984SE |
| K832433 | Automatic Spirometer ST-200BZG · Traditional | 09/29/1983SE |
Questions and answers
When was Model {M-102 I-Channel Electro Cardiograph Unit cleared by the FDA?
Model {M-102 I-Channel Electro Cardiograph Unit (K843934) received a 510(k) decision of Substantially Equivalent on November 20, 1984, 42 days after the submission was received.
What is the product code of K843934?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.