RT40 Radio Translucent
FDA 510(k) K912714 · Bio-Detek, Inc.
510(k) numberK912714
Submission
- Device name
- RT40 Radio Translucent
- Applicant
- Bio-Detek, Inc.
Attleboro, MA, US - Received
- June 18, 1991
- Decision date
- July 25, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 RT40 Radio Translucent cleared by the FDA?
RT40 Radio Translucent (K912714) received a 510(k) decision of Substantially Equivalent on July 25, 1991, 37 days after the submission was received.
What is the product code of K912714?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.