MED2000 Nebulizer Compressor, Models P3, P4, P5 with Nebulizer

FDA 510(k) K041974 · Med2000 S.R.L.

Substantially Equivalent

510(k) numberK041974

Submission

Device name
MED2000 Nebulizer Compressor, Models P3, P4, P5 with Nebulizer
Applicant
Med2000 S.R.L.
Great Neck, NY, US
Received
July 22, 2004
Decision date
August 24, 2004
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

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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More from Medline Industries, Inc.

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K041327MED2000 SPA Nebulizer Andyflow, Model A1/C with AccessoriesCAF · Special 07/20/2004SE
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Questions and answers

When was MED2000 Nebulizer Compressor, Models P3, P4, P5 with Nebulizer cleared by the FDA?

MED2000 Nebulizer Compressor, Models P3, P4, P5 with Nebulizer (K041974) received a 510(k) decision of Substantially Equivalent on August 24, 2004, 33 days after the submission was received.

What is the product code of K041974?

The FDA product code is BTI – Compressor, Air, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.6250.