510(k) K043148
K043148 is an FDA 510(k) premarket notification submitted by Alliance Tech Medical, Inc. for the device "ALL FLOW PULMONARY FUNCTION FILTER". The FDA issued a decision of Substantially Equivalent on Dec 13, 2004. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 13, 2004
- Date Received
- Nov 15, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filter, Bacterial, Breathing-Circuit
- Device Class
- Class II
- Regulation Number
- 868.5260
- Review Panel
- HO
- Submission Type
- 510(k)