SMDIA-1000
FDA 510(k) K101953 · Southmedic, Inc.
510(k) numberK101953
Submission
- Device name
- SMDIA-1000
- Applicant
- Southmedic, Inc.
Bonita Springs, FL, US - Received
- July 12, 2010
- Decision date
- January 7, 2011
- 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 SMDIA-1000 cleared by the FDA?
SMDIA-1000 (K101953) received a 510(k) decision of Substantially Equivalent on January 7, 2011, 179 days after the submission was received.
What is the product code of K101953?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.