MAC 800 Resting ECG Analysis System
FDA 510(k) K142288 · Ge Medical Systems China Co., Ltd.
510(k) numberK142288
Submission
- Device name
- MAC 800 Resting ECG Analysis System
- Applicant
- Ge Medical Systems China Co., Ltd.
Wuxi, CN - Received
- August 18, 2014
- Decision date
- December 3, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DPS – Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2340
- Specialty
- Cardiovascular
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| 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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Questions and answers
When was MAC 800 Resting ECG Analysis System cleared by the FDA?
MAC 800 Resting ECG Analysis System (K142288) received a 510(k) decision of Substantially Equivalent on December 3, 2014, 107 days after the submission was received.
What is the product code of K142288?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.