ECG Modulator
FDA 510(k) K760563 · Physio-Control Corp.
510(k) numberK760563
Submission
- Device name
- ECG Modulator
- Applicant
- Physio-Control Corp.
Mchenry, IL, US - Received
- September 2, 1976
- Decision date
- September 10, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXH – Transmitters And Receivers, Electrocardiograph, Telephone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2920
- Specialty
- Cardiovascular
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| K123597 | Truecpr Coaching DeviceLIX · Traditional | 04/17/2013SE |
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| K103567 | Lifepak 15 Monitor/DefibrillatorMKJ · Traditional | 03/22/2011SE |
| K102972 | Lifepak 12MKJ · Special | 12/22/2010SE |
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Questions and answers
When was ECG Modulator cleared by the FDA?
ECG Modulator (K760563) received a 510(k) decision of Substantially Equivalent on September 10, 1976, 8 days after the submission was received.
What is the product code of K760563?
The FDA product code is DXH – Transmitters And Receivers, Electrocardiograph, Telephone, a Class II (moderate risk) device regulated under 21 CFR 870.2920.