Mister Neb Nebulizer Compressor, with Nebulizer, Model HS123
FDA 510(k) K013027 · Respironics Healthscan, Inc.
510(k) numberK013027
Submission
- Device name
- Mister Neb Nebulizer Compressor, with Nebulizer, Model HS123
- Applicant
- Respironics Healthscan, Inc.
Great Neck, NY, US - Received
- September 10, 2001
- Decision date
- December 6, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- BTI – Compressor, Air, Portable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.6250
- Specialty
- Anesthesiology
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Questions and answers
When was Mister Neb Nebulizer Compressor, with Nebulizer, Model HS123 cleared by the FDA?
Mister Neb Nebulizer Compressor, with Nebulizer, Model HS123 (K013027) received a 510(k) decision of Substantially Equivalent on December 6, 2001, 87 days after the submission was received.
What is the product code of K013027?
The FDA product code is BTI – Compressor, Air, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.6250.