Nebulaire (Irc 1040) Nebulizer Pump
FDA 510(k) K851436 · Invacare Corp.
510(k) numberK851436
Submission
- Device name
- Nebulaire (Irc 1040) Nebulizer Pump
- Applicant
- Invacare Corp.
Elyria, OH, US - Received
- April 10, 1985
- Decision date
- July 8, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Nebulaire (Irc 1040) Nebulizer Pump cleared by the FDA?
Nebulaire (Irc 1040) Nebulizer Pump (K851436) received a 510(k) decision of Substantially Equivalent on July 8, 1985, 89 days after the submission was received.
What is the product code of K851436?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.