Omron Ultrasonic Nebulizer NE-U06
FDA 510(k) K875134 · Nidek, Inc.
510(k) numberK875134
Submission
- Device name
- Omron Ultrasonic Nebulizer NE-U06
- Applicant
- Nidek, Inc.
Birmingham, AL, US - Received
- December 15, 1987
- Decision date
- December 5, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CAF – Nebulizer (Direct Patient Interface)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5630
- Specialty
- Anesthesiology
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Questions and answers
When was Omron Ultrasonic Nebulizer NE-U06 cleared by the FDA?
Omron Ultrasonic Nebulizer NE-U06 (K875134) received a 510(k) decision of Substantially Equivalent on December 5, 1988, 356 days after the submission was received.
What is the product code of K875134?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.