Post Extra Systolic Potentiator
FDA 510(k) K781819 · Medrad, Inc.
510(k) numberK781819
Submission
- Device name
- Post Extra Systolic Potentiator
- Applicant
- Medrad, Inc.
Mchenry, IL, US - Received
- October 27, 1978
- Decision date
- January 15, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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Questions and answers
When was Post Extra Systolic Potentiator cleared by the FDA?
Post Extra Systolic Potentiator (K781819) received a 510(k) decision of Substantially Equivalent on January 15, 1979, 80 days after the submission was received.
What is the product code of K781819?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.