Schuco Mist and Schuco Deluxe Mist
FDA 510(k) K051260 · Allied Healthcare Products, Inc.
510(k) numberK051260
Submission
- Device name
- Schuco Mist and Schuco Deluxe Mist
- Applicant
- Allied Healthcare Products, Inc.
Saint Louis, MO, US - Received
- May 15, 2005
- Decision date
- September 15, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Schuco Mist and Schuco Deluxe Mist cleared by the FDA?
Schuco Mist and Schuco Deluxe Mist (K051260) received a 510(k) decision of Substantially Equivalent on September 15, 2005, 123 days after the submission was received.
What is the product code of K051260?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.