Metered Dose Inhaler Adapter-Disposable, Adapter Reusable
FDA 510(k) K991355 · Instrumentation Industries, Inc.
510(k) numberK991355
Submission
- Device name
- Metered Dose Inhaler Adapter-Disposable, Adapter Reusable
- Applicant
- Instrumentation Industries, Inc.
Bethel Park, PA, US - Received
- April 19, 1999
- Decision date
- January 27, 2000
- 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 Metered Dose Inhaler Adapter-Disposable, Adapter Reusable cleared by the FDA?
Metered Dose Inhaler Adapter-Disposable, Adapter Reusable (K991355) received a 510(k) decision of Substantially Equivalent on January 27, 2000, 283 days after the submission was received.
What is the product code of K991355?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.