Ambu Blue Sensor, MRX, ECG Electrode Product #:MRX-00-S
FDA 510(k) K041026 · Ambu, Inc.
510(k) numberK041026
Submission
- Device name
- Ambu Blue Sensor, MRX, ECG Electrode Product #:MRX-00-S
- Applicant
- Ambu, Inc.
Linthicum, MD, US - Received
- April 21, 2004
- Decision date
- June 28, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 Ambu Blue Sensor, MRX, ECG Electrode Product #:MRX-00-S cleared by the FDA?
Ambu Blue Sensor, MRX, ECG Electrode Product #:MRX-00-S (K041026) received a 510(k) decision of Substantially Equivalent on June 28, 2004, 68 days after the submission was received.
What is the product code of K041026?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.