Rhino-Guard
FDA 510(k) K911785 · Micromedics, Inc.
510(k) numberK911785
Submission
- Device name
- Rhino-Guard
- Applicant
- Micromedics, Inc.
St. Paul, MN, US - Received
- April 22, 1991
- Decision date
- October 7, 1991
- 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 Rhino-Guard cleared by the FDA?
Rhino-Guard (K911785) received a 510(k) decision of Substantially Equivalent on October 7, 1991, 168 days after the submission was received.
What is the product code of K911785?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.