800 Series Easyneb Nebulizer
FDA 510(k) K020357 · Nellcor Puritan Bennett, Inc.
510(k) numberK020357
Submission
- Device name
- 800 Series Easyneb Nebulizer
- Applicant
- Nellcor Puritan Bennett, Inc.
Pleasanton, CA, US - Received
- February 4, 2002
- Decision date
- August 7, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 800 Series Easyneb Nebulizer cleared by the FDA?
800 Series Easyneb Nebulizer (K020357) received a 510(k) decision of Substantially Equivalent on August 7, 2002, 184 days after the submission was received.
What is the product code of K020357?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.