Endomed CV405
FDA 510(k) K880699 · Henley Intl.
510(k) numberK880699
Submission
- Device name
- Endomed CV405
- Applicant
- Henley Intl.
Houston, TX, US - Received
- February 22, 1988
- Decision date
- May 2, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IPF – Stimulator, Muscle, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
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| K922036 | Sonopuls 591IMG · Traditional | 06/29/1993SE |
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Questions and answers
When was Endomed CV405 cleared by the FDA?
Endomed CV405 (K880699) received a 510(k) decision of Substantially Equivalent on May 2, 1988, 70 days after the submission was received.
What is the product code of K880699?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.