Circuit, Printed, Servo-Mechanism
FDA 510(k) K760272 · Burdick Corp.
510(k) numberK760272
Submission
- Device name
- Circuit, Printed, Servo-Mechanism
- Applicant
- Burdick Corp.
Mchenry, IL, US - Received
- July 22, 1976
- Decision date
- November 12, 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 |
More from Masimo Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K952417 | Quest Exercise Stress SystemDSI · Traditional | 05/22/1996SE |
| K954267 | Burdick 200 Pulse OximeterDQA · Traditional | 05/03/1996SE |
| K946281 | Eclipse 4 ElectrocardiographLOS · Traditional | 04/23/1996SE |
| K945985 | PC Holter Scanning System Simplicity, Altair 8200, 8300, 8400DQK · Traditional | 07/03/1995SE |
| K943959 | Eclipse 4 ElectrocardiographLOS · Traditional | 05/17/1995SE |
| K942565 | Altair-Disc RecorderDQK · Traditional | 12/05/1994SE |
| K941351 | Burdick PRO2 OximeterDQA · Traditional | 10/13/1994SE |
| K942438 | Altair 6100 Cassette RecorderDSH · Traditional | 08/05/1994SE |
| K904032 | Elite II ElectrocardiographLOS · Traditional | 07/24/1991SE |
| K903565 | E560 ElectrocardiographLOS · Traditional | 07/24/1991SE |
Questions and answers
When was Circuit, Printed, Servo-Mechanism cleared by the FDA?
Circuit, Printed, Servo-Mechanism (K760272) received a 510(k) decision of Substantially Equivalent on November 12, 1976, 113 days after the submission was received.
What is the product code of K760272?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.