Aeromist LT, Model HCS15004
FDA 510(k) K031686 · Medline Industries, Inc.
510(k) numberK031686
Submission
- Device name
- Aeromist LT, Model HCS15004
- Applicant
- Medline Industries, Inc.
Mundelein, IL, US - Received
- June 2, 2003
- Decision date
- January 21, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 Aeromist LT, Model HCS15004 cleared by the FDA?
Aeromist LT, Model HCS15004 (K031686) received a 510(k) decision of Substantially Equivalent on January 21, 2004, 233 days after the submission was received.
What is the product code of K031686?
The FDA product code is BTI – Compressor, Air, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.6250.