Model VY-800RA Optional Accessory to BSM 8500A
FDA 510(k) K883973 · Nihon Kohden America, Inc.
510(k) numberK883973
Submission
- Device name
- Model VY-800RA Optional Accessory to BSM 8500A
- Applicant
- Nihon Kohden America, Inc.
Irvine, CA, US - Received
- September 20, 1988
- Decision date
- November 9, 1988
- 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 Model VY-800RA Optional Accessory to BSM 8500A cleared by the FDA?
Model VY-800RA Optional Accessory to BSM 8500A (K883973) received a 510(k) decision of Substantially Equivalent on November 9, 1988, 50 days after the submission was received.
What is the product code of K883973?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.