Ipco M-101 Echocardiograph (Ipco Ultra-
FDA 510(k) K792373 · Ipco Corp.
510(k) numberK792373
Submission
- Device name
- Ipco M-101 Echocardiograph (Ipco Ultra-
- Applicant
- Ipco Corp.
Walker, MI, US - Received
- November 26, 1979
- Decision date
- February 13, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXK – Echocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2330
- Specialty
- Cardiovascular
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Questions and answers
When was Ipco M-101 Echocardiograph (Ipco Ultra- cleared by the FDA?
Ipco M-101 Echocardiograph (Ipco Ultra- (K792373) received a 510(k) decision of Substantially Equivalent on February 13, 1980, 79 days after the submission was received.
What is the product code of K792373?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.