Citadel Reference Electrode
FDA 510(k) K770477 · Sherwood Medical Industries
510(k) numberK770477
Submission
- Device name
- Citadel Reference Electrode
- Applicant
- Sherwood Medical Industries
Mchenry, IL, US - Received
- March 11, 1977
- Decision date
- March 30, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRF – Catheter, Electrode Recording, Or Probe, Electrode Recording
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1220
- Specialty
- Cardiovascular
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Questions and answers
When was Citadel Reference Electrode cleared by the FDA?
Citadel Reference Electrode (K770477) received a 510(k) decision of Substantially Equivalent on March 30, 1977, 19 days after the submission was received.
What is the product code of K770477?
The FDA product code is DRF – Catheter, Electrode Recording, Or Probe, Electrode Recording, a Class II (moderate risk) device regulated under 21 CFR 870.1220.