Model 375 ECG
FDA 510(k) K881328 · Birtcher Corp.
510(k) numberK881328
Submission
- Device name
- Model 375 ECG
- Applicant
- Birtcher Corp.
El Monte, CA, US - Received
- March 29, 1988
- Decision date
- May 18, 1988
- 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 |
|---|---|---|
| K860718 | Electrosurgery Pencil, Model 767GEI · Traditional | 03/24/1986SE |
| K860687 | Birt-A-Switch, DSP Push Button, Model No. 768GEI · Traditional | 03/24/1986SE |
| K854814 | Surgical Cauteries Models 775-11,12,13,31,32 & 33GEI · Traditional | 01/13/1986SE |
| K854864 | Bi-Polar ForcepsGEI · Traditional | 12/24/1985SE |
| K850943 | Model 775 Bipolar CoagulatorGEI · Traditional | 05/20/1985SE |
| K850668 | Electrosurgical Unit 774GEI · Traditional | 05/20/1985SE |
| K844101 | Cardio-Nec Model 365DPS · Traditional | 04/09/1985SE |
| K844104 | Cardio Analyzer Model 380LOS · Traditional | 03/06/1985SE |
| K850297 | Electrosurgical Pencil Holder 720GEI · Traditional | 02/28/1985SE |
| K844103 | Cardiopac Defibrillator 444LDD · Traditional | 01/18/1985SE |
Questions and answers
When was Model 375 ECG cleared by the FDA?
Model 375 ECG (K881328) received a 510(k) decision of Substantially Equivalent on May 18, 1988, 50 days after the submission was received.
What is the product code of K881328?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.