ECG Electrodes, Pediatric-Microporous Ta
FDA 510(k) K791003 · Physio-Control Corp.
510(k) numberK791003
Submission
- Device name
- ECG Electrodes, Pediatric-Microporous Ta
- Applicant
- Physio-Control Corp.
Mchenry, IL, US - Received
- May 29, 1979
- Decision date
- June 1, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRX – Electrode, Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2360
- Specialty
- Cardiovascular
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Questions and answers
When was ECG Electrodes, Pediatric-Microporous Ta cleared by the FDA?
ECG Electrodes, Pediatric-Microporous Ta (K791003) received a 510(k) decision of Substantially Equivalent on June 1, 1979, 3 days after the submission was received.
What is the product code of K791003?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.