510(k) K871366
K871366 is an FDA 510(k) premarket notification submitted by Siemens Elema AB for the device "SIEMENS MAIN FLOW BACTERIA FILTER". The FDA issued a decision of Substantially Equivalent on May 14, 1987. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Siemens Elema AB has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 14, 1987
- Date Received
- April 7, 1987
- 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