Cardimax FX-1164
FDA 510(k) K853979 · Brentwood Instruments, Inc.
510(k) numberK853979
Submission
- Device name
- Cardimax FX-1164
- Applicant
- Brentwood Instruments, Inc.
Torrance, CA, US - Received
- September 26, 1985
- Decision date
- February 6, 1986
- 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 |
|---|---|---|
| K896924 | Spiroscan 4000BZG · Traditional | 03/01/1990SE |
| K882366 | Rhythmscan HR Holter RecorderDSH · Traditional | 08/02/1988SE |
| K871572 | RhythmscanDSI · Traditional | 02/22/1988SE |
| K860024 | Fukuda Denshi Cardimax FCP-211DSI · Traditional | 03/31/1986SE |
| K854505 | Cardimax FX-406UDRS · Traditional | 02/04/1986SE |
| K851135 | Spiro ScanBZG · Traditional | 07/01/1985SE |
| K851124 | T-1000 ECG TransmitterDXH · Traditional | 05/15/1985SE |
| K851123 | R-1000 ECG ReceiverDXH · Traditional | 05/15/1985SE |
| K842976 | Brentwood Ez Scan 200 Ambulatory ECGDSI · Traditional | 03/01/1985SE |
| K844470 | Fukuda Denshi Model FCP-220DPS · Traditional | 01/10/1985SE |
Questions and answers
When was Cardimax FX-1164 cleared by the FDA?
Cardimax FX-1164 (K853979) received a 510(k) decision of Substantially Equivalent on February 6, 1986, 133 days after the submission was received.
What is the product code of K853979?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.