Medical Oscilloscope Memory Scope
FDA 510(k) K760721 · Abbott Laboratories
510(k) numberK760721
Submission
- Device name
- Medical Oscilloscope Memory Scope
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- September 27, 1976
- Decision date
- October 6, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXJ – Display, Cathode-Ray Tube, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2450
- Specialty
- Cardiovascular
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Questions and answers
When was Medical Oscilloscope Memory Scope cleared by the FDA?
Medical Oscilloscope Memory Scope (K760721) received a 510(k) decision of Substantially Equivalent on October 6, 1976, 9 days after the submission was received.
What is the product code of K760721?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.