510(k) K953687
K953687 is an FDA 510(k) premarket notification submitted by Westmed Intl. for the device "WESTMED PEDIATRIC BACTERIAL/VIRAL FILTER". The FDA issued a decision of Substantially Equivalent on September 18, 1995. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Westmed Intl. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 1995
- Date Received
- August 7, 1995
- 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