Nihon Kohden Blood Flowmeters #MFV-1100
FDA 510(k) K820742 · Nihon Kohden America, Inc.
510(k) numberK820742
Submission
- Device name
- Nihon Kohden Blood Flowmeters #MFV-1100
- Applicant
- Nihon Kohden America, Inc.
Foothill, CA, US - Received
- March 18, 1982
- Decision date
- April 15, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2100
- Specialty
- Cardiovascular
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Questions and answers
When was Nihon Kohden Blood Flowmeters #MFV-1100 cleared by the FDA?
Nihon Kohden Blood Flowmeters #MFV-1100 (K820742) received a 510(k) decision of Substantially Equivalent on April 15, 1982, 28 days after the submission was received.
What is the product code of K820742?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.