510(k) K031686
K031686 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "AEROMIST LT, MODEL HCS15004". The FDA issued a decision of Substantially Equivalent on January 21, 2004. The device falls under product code BTI (Compressor, Air, Portable), a Class II device regulated under 21 CFR 868.6250. Medline Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 2004
- Date Received
- June 2, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Compressor, Air, Portable
- Device Class
- Class II
- Regulation Number
- 868.6250
- Review Panel
- AN
- Submission Type